Novation 130-32-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885862022172), received between Mar 30, 2021 and Nov 18, 2025 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (33 reports).

2 FDA recall records name this device's identifier, 2 still open.

14 other recalls cover devices cleared under the same FDA submission (K070479); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1729-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2117-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  THE PATIENT PRESENTED FOR A FOLLOW-UP EXAMINATION. X-RAY AND CT SCANS SHOWED SLIGHT DECENTERING OF THE PROSTHETIC HEAD ON THE RIGHT SIDE AND MINOR OSTEOLYSIS IN THE ACETABULUM, INDICATING PREMATURE INLAY WEAR. THIS WAS ADDRESSED DURING AN INLAY REPLACEMENT PROCEDURE, USING A SPECIALLY APPROVED VITAMIN E-HARDENED INLAY. THE PROCEDURE INVOLVED VERIFICATION. DURING THE REVISION SURGERY, IN ADDITION TO REPLACING THE INLAY, THE INTEGRITY OF THE ACETABULAR SOCKET WAS ASSESSED, THE CYSTS IN THE ACETABULAR BED WERE CURETTED AND FILLED WITH HYDROXYLAPATITE + CALCIUM (CERAMENT BONE VOID FILLER), AND THE PROSTHETIC HEAD WAS REPLACED.

  Patient problems: Cyst(s); Insufficient Information; Osteolysis

  MAUDE report 23578390 ↗
• InjuryMay 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS INFORMED THAT DUE TO THE POSSIBILITY OF PREMATURE WEAR OF THE PLASTIC INLAY DUE TO THE DEFECT, A REPEAT OPERATION WITH REPLACEMENT OF THE PROSTHESIS WOULD BE NECESSARY. THE IMPLANT HAS NOT YET BEEN REPLACED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22061378 ↗
• InjuryOct 16, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 1 MONTH POST INITIAL IMPLANT, AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A SLIGHT DECENTRATION OF THE PROSTHESIS HEAD AND SMALL OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. REVISION SURGERY WAS THEN PERFORMED AT WHICH TIME THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.

  Patient problems: Osteolysis

  MAUDE report 20465418 ↗
• InjuryOct 8, 2024Naturally Worn; Naturally Worn

  IN 2015, THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2024 TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 3, 36 MM I.D., REF: 140-36-53, SN: (B)(6). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE CUP BED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED. NO FURTHER INFORMATION.

  Patient problems: Cyst(s); Osteolysis

  MAUDE report 20403104 ↗
• InjuryOct 7, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. DURING THE PLANNED REPLACEMENT SURGERY, AN ANAPHYLACTIC REACTION OCCURRED DURING THE INDUCTION OF ANESTHESIA, SO THAT THE SURGERY COULD NOT BE PERFORMED. THE ALLERGIC REACTION IS DUE TO THE PREOPERATIVE ADMINISTRATION OF CEFAZOLIN FOR PERIOPERATIVE INFECTION PROPHYLAXIS.

  Patient problems: Osteolysis

  MAUDE report 20392477 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED ONLY SMALL OSTEOLYSES AND AT MOST A SLIGHT DECENTRATION OF THE PROSTHESIS HEAD. HOWEVER, THE PATIENT WAS SO CONCERNED ABOUT THE RECALL THAT THE INDICATION FOR AN INLAY CHANGE WAS MADE. THE PATIENT WAS REVISED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS REPLACED.

  Patient problems: Osteolysis

  MAUDE report 20349166 ↗
• InjurySep 25, 2024Naturally Worn; Naturally Worn

  THE PATIENT HAD A HIP PROSTHESIS CUP IMPLANTED. THE PATIENT PRESENTED FOR FOLLOW-UP WITH AN EXTERNALLY DIAGNOSED DECENTRATION OF THE PROSTHESIS HEAD IN THE CUP BEARING. THE X-RAY AND CT SCAN SHOWED A MODERATE DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED. DURING THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE CUP WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURETTAGED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS REPLACED.

  Patient problems: Osteolysis

  MAUDE report 20306143 ↗
• InjurySep 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S HIP WAS REVISED APPROXIMATELY 8 YEARS 6 MONTHS POST OP. IN 2015, THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED ON THE LEFT. IN PREPARATION FOR THE IMPLANTATION OF A HIP PROSTHESIS ON THE RIGHT IN 2022, A DECENTRATION OF THE INLAY ON THE LEFT WAS ALREADY NOTICED. SINCE THE PATIENT WAS SYMPTOM-FREE, THE IMPLANTATION WAS INITIALLY CARRIED OUT ON THE RIGHT AND CHECK-UPS ON THE LEFT SIDE WERE AGREED EVERY 6 MONTHS. AS PART OF THE MANUFACTURER'S RECALL AND THE PLANNED CHECK-UPS, THE PATIENT PRESENTED FOR FURTHER CHECK-UPS. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND MINOR OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. WITH NOW INCREASING, MILD COMPLAINTS ON THE LEFT SIDE, THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 3, 36 MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE SOCKET WAS DETERMINED, THE CYSTS IN THE SOCKET WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS REPLACED..

  Patient problems: Osteolysis

  MAUDE report 20242432 ↗
• InjurySep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S HIP WAS REVISED APPROXIMATELY 4 YEARS 6 MONTHS POST OP. THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. DURING THE COURSE OF THE PROCEDURE, THE STEM BECAME LOOSE AND SINTERED, WHICH IS WHY A STEM REPLACEMENT OPERATION WAS CARRIED OUT, DURING WHICH THE CUP INLAY WAS ALSO REPLACED (OLD: NOVATION CROWN CUP, CONNEXION GXL, NEUTRAL LINER, GROUP 3, 32MM). AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A SLIGHT DECENTRATION OF THE PROSTHESIS HEAD, SMALL OSTEOLYSES IN THE ACETABULUM AND A LARGER OSTEOLYSIS IN THE STEM AREA AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED DURING AN INLAY CHANGE TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 3, 36 MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE CUP AND SHAFT WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURETTAGED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS REPLACED.

  Patient problems: Osteolysis

  MAUDE report 20233573 ↗
• InjuryAug 8, 2024Naturally Worn; Naturally Worn

  THE PATIENT WAS IMPLANTED WITH A HIP PROSTHETIC CUP FROM EXACTECH. AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED FOR A CHECK-UP. IN THE X-RAY CONTROL, THERE WAS A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM. AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VITD-HARDENED ONE ON (B)(6) 2024 SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 3, 36MM I.D., REF (B)(4), SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED, CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19940786 ↗
• InjuryJun 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL RIGHT HIP IMPLANTED IN 2017, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS POST THE INITIAL PROCEDURE. THE PATIENT HAD PRESENTED WITH RIGHT HIP PAIN. DURING THE PROCEDURE THE FEMUR WAS DISLOCATED, AND THE FEMORAL HEAD WAS REMOVED. THE STEM WAS CHECKED AND FOUND TO BE WELL FIXED. ATTENTION TURNED TO CUP. THE POLY LINER WAS REMOVED WITH THE HELP OF A BONE SCREW. THE CUP WAS FOUND TO BE WELL FIXED. THE PATIENT RECEIVED A G3 EXTENDED COVERAGE 36MM LINER AND A 36 +10 COCR HEAD. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE PATIENT REQUESTED THEM. NO DEVICE IMAGES WERE PROVIDED.

  Patient problems: Implant Pain

  MAUDE report 19640970 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S HIP WAS REVISED APPROXIMATELY 5 YEARS 2 MONTHS POST OP. THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED IN 2019. HE CAME IN FOR A CHECK-UP IN (B)(6) 2023 BECAUSE OF PAIN THAT HAD BEEN PRESENT FOR MONTHS WITH SUSPECTED LOOSENING OF THE PROSTHESIS. THE X-RAY AND CT SCAN SHOWED MINIMAL DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY PRONOUNCED OSTEOLYSIS IN THE ACETABULUM. A SKELETAL SCINTIGRAPHY WAS PERFORMED TO RULE OUT LOOSENING AND THEN THE INDICATION FOR AN INLAY CHANGE WAS MADE. THIS WAS DONE IN (B)(6) 2024 ON A VIT E-HARDENED SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE SOCKET WAS DETERMINED, THE CYSTS IN THE SOCKET WERE CURETTAGED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS REPLACED.

  Patient problems: Insufficient Information; Osteolysis; Pain

  MAUDE report 19619920 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE CUP WAS CHANGED ON (B)(6) 2024 TO A REVISION COMPETITOR'S HIP CUP. AS PART OF THE REPLACEMENT OPERATION, THE PROSTHESIS HEAD WAS REPLACED IN ADDITION TO THE CUP REPLACEMENT.

  Patient problems: Osteolysis

  MAUDE report 19570821 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  THE PATIENT WAS IMPLANTED WITH A HIP PROSTHETIC CUP FROM EXACTECH. AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED FOR A CHECK-UP. THE X-RAY AND CT CHECK SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2024 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 3, 36 MM I.D., REF 140-36-53, SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRM SOCKET INTEGRITY WAS DETERMINED AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND THE REPLACEMENT OF THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant

  MAUDE report 19360520 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  THE PATIENT PRESENTED FOR A CHECK-UP. IN THE X-RAY CONTROL, THERE WAS A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM, AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VITD-HARDENED ONE, A SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 3, 36 MM, I.D., REF (B)(4), SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED, SOCKET INTEGRITY AND THE REPLACEMENT OF THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant

  MAUDE report 19323304 ↗
• InjuryApr 24, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL HIP ARTHROPLASTY ON (B)(6) 2018 AND HAS A PLANNED REVISION PROCEDURE FOR (B)(6) 2024. THERE IS NO OTHER INFORMATION PROVIDED OR AVAILABLE.

  Patient problems: Cyst(s); Insufficient Information; Osteolysis

  MAUDE report 19176089 ↗
• InjuryApr 12, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT WHO HAD AN INITIAL LEFT HIP IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR AND WAS REVISED TO A 140-36-53 CC INLAY VITAMIN E, NEUTRAL, Ø 36, GR. 3 6600067. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19095163 ↗
• InjuryMar 18, 2024Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED FOR A NEW CHECK-UP. IN THE X-RAY AND CT CONTROL SHOWED THE WELL-KNOWN CLEAR DECENTERING OF THE PROSTHETIC HEAD AND A CLEAR INCREASE IN SIZE OF THE KNOWN LYSIS IN THE ACETABULUM. THAT'S WHY THE REVISION AND CHANGE TOOK PLACE ON (B)(6) 2024 ON A VITE-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 3, 36 MM I.D., REF 140-36-53, SN: (B)(6). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Failure of Implant; Osteolysis; Pain

  MAUDE report 18927394 ↗
• InjuryFeb 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN APPROXIMATELY 59 YO PATIENT, INITIAL HIP IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED TO HAVE THE HIP PROSTHESIS IMPLANTED IN 2020 CHECKED. X-RAY CONTROL SHOWED A SLIGHT DECENTERING OF THE PROSTHESIS HEAD AND SMALL OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2024, TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 3, 36 MM I.D., REF 140-36-53, SN (B)(6). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE SOLID INTEGRITY OF THE SOCKET WAS DETERMINED AS WELL AS THE CURETTAGE OF THE SMALL CYSTS IN THE SOCKET AND THE REPLACEMENT OF THE PROSTHETIC HEAD. DIAGNOSIS THAT LED TO IMPLANTATION: PRIMARY COXARTHROSIS M16.1 IMPLANTING CLINIC: BWKRHS WESTERSTEDE. ITEM DATA FOR THE IMPLANTATION AND REPLACEMENT, AS WELL AS PHOTOS OF THE EXPLANTS, WILL BE SUBMITTED AFTER RECEIPT OF A CONFIRMATION OF RECEIPT WITH BFARM CASE NUMBER. THE EXPLANTS ARE CURRENTLY IN THE OSNABRÜCK LABORATORY DOCTOR'S OFFICE (R

  Patient problems: Osteolysis

  MAUDE report 18758574 ↗
• InjuryFeb 19, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE GERMANY COMPETENT AUTHORITIES AND AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED HIMSELF FOR A CHECK-UP OF THE DEVICE IMPLANTED IN 2016 HIP PROSTHESIS. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS COULD HAPPEN TO ONE. INLAY CHANGE ON (B)(6) 2024 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 3, 36 MM I.D., REF 140-36-53, SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, AFTER THE INLAY EXCHANGE, THE DETERMINATION OF THE SOLID CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS. SOCKET BEARING USING ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis

  MAUDE report 18733777 ↗
• InjuryFeb 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE GERMANY COMPETENT AUTHORITIES AND AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT WENT TO HAVE BOTH HIP PROSTHESES CHECKED (LEFT IMPLANTED IN 2019, RIGHT IN 2021). THE X-RAY AND CT CHECK SHOWED CLEAR DECENTRATION BOTH PROSTHETIC HEADS WITH UNUSUALLY LARGE OSTEOLYSIS IN BOTH ACETABULA AS A SIGN OF PREMATURE INLAY WEAR. FIRST, THE RIGHT SIDE WAS REVISED ON (B)(6) 2023. THE SUSPECTED DIAGNOSIS WAS CONFIRMED AND THE INLAY WAS REPLACED WITH A SPECIALLY APPROVED VITD-HARDENED ONE INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 3, 36 MM I.D., REF 140-36-53, SN (B)(6)). AS PART OF THE EXCHANGE OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE SOLID CUP INTEGRITY WAS DETERMINED AS WELL AS CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD. THE EXPLANTS ARE CURRENTLY WITH HOSPITAL AND WILL BE RETURNED TO THE PATIENT AT THEIR OWN REQUEST HANDED OUT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18679010 ↗
• InjuryJan 9, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. PATIENT WAS REVISED TO CC INLAY VITAMIN E, NEUTRAL, Ø 36, GR. 3 (CAT# 140-36-63 / SERIAL# (B)(6). NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Cyst(s); Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 18480248 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 67 YO MALE PATIENT, INITIAL HIP IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED HIMSELF FOR A CHECKUP OF THE DEVICES IMPLANTED IN HIS 2019 HIP PROSTHESIS. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THE GXL INSERT WAS REPLACED WITH AN 140-36-53 CC INLAY VITAMIN E, NEUTRAL, Ø 36, GR. 3. AS PART OF THE REPLACEMENT OPERATION, THE INLAY WAS EXCHANGED, DETERMINATION OF SOLID CUP INTEGRITY, AS WELL AS CURETTAGE AND SEALING OF THE CYSTS, SOCKET BEARING USING ALLOGENEIC CANCELLOUS BONE, AND CHANGING THE PROSTHETIC HEAD WAS PERFORMED. DEVICE RETURNS AVAILABLE IF THE PATIENT MAKES THEM AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Cyst(s); Insufficient Information; Osteolysis

  MAUDE report 18351807 ↗
• InjuryDec 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE GERMANY COMPETENT AUTHORITIES, THE PATIENT PRESENTED FOR SEVERAL FOLLOW-UP CHECKS WITH PERSISTENT SYMPTOMS ON THE OPPOSITE SIDE. THE X-RAY CONTROL REVEALED A CLEAR DECENTERING OF THE PROSTHETIC HEAD. THE CT SCAN ALSO SHOWED OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF PREMATURE INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER GROUP 3, 36 MM I.D). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRM SOCKET INTEGRITY WAS DETERMINED AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND THE REPLACEMENT OF THE PROSTHETIC HEAD. THE EXPLANTS ARE CURRENTLY IN THE LABORATORY DOCTOR'S OFFICE FOR MICROBIOLOGICAL EXAMINATION USING SONICATION. AFTER THE EXAMINATION (14 DAYS OF LONG-TERM INCUBATION).

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18330501 ↗
• InjuryDec 7, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT WAS REVISED 8 YEARS POSTOP INITIAL THA. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD, UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS COULD HAPPEN TO ONE. INLAY CHANGE ON NOVEMBER 15, 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE SOLID CUP INTEGRITY WAS DETERMINED AS WELL AS CURETTAGE AND SEALING THE CYSTS IN THE SOCKET USING ALLOGENEIC SPONGIOSA AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Cyst(s); Failure of Implant; Osteolysis

  MAUDE report 18284459 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070479. One submission often covers many models, so check the product and lot details in each record.

• Z-2126-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner,
• Z-2123-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
• Z-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;
• Z-2132-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL a
• Z-2118-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
• Z-2127-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant
• Z-2128-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant
• Z-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
• Z-2120-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant
• Z-2116-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28m
• Z-2133-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
• Z-2122-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped A
• Z-0788-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip r
• Z-0787-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replaceme