Novation 136-32-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885862024282), received between Mar 30, 2021 and Aug 12, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Naturally Worn” (25 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-2127-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO HAD A HIP IMPLANTED, UNDERWENT A REVISION PROCEDURE. REASON UNKNOWN. THE LINER WAS REVISED. NO FURTHER INFORMATION.

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

  MAUDE report 22789833 ↗
• InjuryApr 11, 2025Naturally Worn; Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT A REVISION OF THEIR HIP LINER. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

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

  MAUDE report 21829595 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED. 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 OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, +5MM LATERALIZED LINER, GROUP 2, 36MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE CUP WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.

  Patient problems: Osteolysis

  MAUDE report 21035220 ↗
• InjuryDec 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED. 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 OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, +5MM LATERALIZED LINER, GROUP 2, 36MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE CUP WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.

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

  MAUDE report 20951577 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT REVISION OF THE TOTAL HIP ARTHROPLASTY (THA). INITIAL IMPLANT DATE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20885336 ↗
• InjuryJul 26, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 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 SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE +5MM LATERALIZED LINER, GROUP2, 36 MM. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM SOCKET INTEGRITY WAS DETERMINED, THE CYSTS IN THE SOCKET WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 19840793 ↗
• InjuryJun 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED. THE PATIENT WAS IMPLANTED WITH A HIP PROSTHETIC CUP FROM EXACTECH. AS PART OF A CONTROL EXAMINATION FOR MINOR COMPLAINTS NEAR THE HIP JOINT, ONE OCCURRED IN (B)(6) 2022 DECENTERING OF THE INLAY. AS THE PATIENT PROGRESSED, HE WAS SYMPTOM-FREE, SO HE WAS ONLY TREATED DURING THE COURSE OF TREATMENT THE MANUFACTURER'S RECALL CAMPAIGN WAS PRESENTED AGAIN. THE X-RAY CONTROL SHOWED A CLEAR DECENTRATION OF THE PROSTHETIC HEAD AND OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS COULD HAPPEN TO ONE INLAY CHANGE TO A VITE-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 CALCIUM/HYDROXYAPATITE (CERAMIC BONE FILLER) AND CHANGING THE PROSTHETIC HEAD. THE EXPLANTS ARE CURRENTLY IN THE LABORATORY DOCTOR'S OFFICE.

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

  MAUDE report 19538447 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE GERMANY COMPETENT AUTHORITIES, AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE MALE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY COARSE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2024, FOR A VITE-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, +5MM LATERALIZED LINER, GROUP 2, I.D. 36MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM SOCKET INTEGRITY WAS DETERMINED, AS WELL AS CURETTAGE AND FILLING OF THE CYSTS IN THE SOCKET USING CERAMENT BONE FILLER AND THE PROSTHESIS HEAD WAS CHANGED. THE EXPLANTS ARE CURRENTLY IN THE HOSPITAL¿S LABORATORY PRACTICE FOR MICROBIOLOGICAL EXAMINATION USING SONICATION.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19469085 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, POLYETHYLENE WEAR, AND DISLOCATION. WEAR WAS NOTED ON THE X-RAY, AND IT WAS CONFIRMED IN THE LEGAL DOCUMENTATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Distress; Failure of Implant; Implant Pain; Joint Dislocation; Osteolysis

  MAUDE report 19329825 ↗
• InjuryMay 6, 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 HERSELF 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 POSSIBLE WHEN THE INLAY WAS CHANGED TO A VITD-HARDENED ONE ON (B)(6) 2024 SPECIALLY APPROVED INLAY (NOVATION XLE +5MM LATERALIZED LINER, GROUP 2, 36 MM I.D., REF (B)(4), SN (B)(6)) BE VERIFIED. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED, SOCKET INTEGRITY OF THE REPLACEMENT OF THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19256329 ↗
• InjuryMar 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION FROM OUS THAT A PATIENT HAD A TOTAL HIP ARTHROPLASTY FOR AN UNKNOWN SIDE ON (B)(6) 2015. IT IS STATED THAT DURING AN EXAMINATION ON (B)(6) 2023, "IT WAS FOUND THAT A SLIGHT DECENTRATION OF THE FEMORAL HEAD IN THE SOCKET WAS A SIGN OF (PREMATURE; AUTHOR'S NOTE) INLAY WEAR." THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18855004 ↗
• InjuryFeb 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION FROM GERMANY THAT A PATIENT HAD A LEFT HIP ARTHROPLASTY ON (B)(6) 2018 AND IS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2024. INLAY WEAR, LEFT HIP JOINT ENDOPROSTHESIS, IMPLANTATION (B)(6) 2018 IT IS NOTED THAT THERE IS A CLEAR DECENTERING ON THE LEFT SIDE OF THE FEMORAL HEAD IN A LATERAL-CRANIAL DIRECTION WITH SUSPICION OF LYSIS IN THE ACETABULUM. THE ADDITIONAL CT SCAN OF THE PELVIS CONFIRMED THIS SUSPICION OF INLAY WEAR THAT HAD ALREADY BEEN EXPRESSED CONVENTIONALLY BY RADIOLOGY WHEN DECENTERING THE FEMORAL HEADS IN THE ARTIFICIAL JOINTS AND ALSO THE EVIDENCE OF LARGE-VOLUME CYSTIC OSTEOLYSIS AT LEVEL THE HIP JOINT SOCKETS. THIS IS BECAUSE THE POLYETHYLENE COATING IS LOOSE AND LEADS TO OSTEOLYSIS. DIAGNOSIS: INLAY WEAR, LEFT HIP JOINT ENDOPROSTHESIS, IMPLANTATION (B)(6) 2018. RIGHT HIP JOINT ENDOPROSTHESIS, IMPLANTATION (B)(6) 2013. CASE HISTORY: THE PATIENT PRESENTED AS PART OF EXACTECH'S RECALL CAMPAIGN FOR A CHECK-UP OF THE HIP JOINTS ON BOTH SIDES. HE REPORTS THAT HE HAS SLIGHT DISCOMFORT ON HIS LEFT SIDE, WHICH FEELS LIKE THE FEMORAL HEAD HITTING THE EDGE OF THE SOCKET EARLY ON. THE RIGHT HIP IS FREE OF SYMPTOMS. FINDING: THE PATIENT

  Patient problems: Osteolysis; Pain

  MAUDE report 18715868 ↗
• InjuryFeb 9, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2024; REASON UNKNOWN. NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18677958 ↗
• InjuryJan 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA OUS LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2016. BASED ON THE SUBSEQUENT FINDINGS AND EXAMINATIONS CARRIED OUT BY THE HOSPITAL, IT WAS DETERMINED THAT THE PROSTHETIC HEAD NEEDED TO BE REVISED. THE PATIENT HAS ADVANCED COXARTHROSIS. THE PATIENT IS SCHEDULED TO HAVE REVISION SURGERY ON (B)(6) 2024. NO REVISION AT THIS TIME. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18494183 ↗
• InjuryDec 13, 2023Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT CAME IN TO HAVE THE HIP PROSTHESIS IMPLANTED IN 2017 CHECKED. X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS SIGNS 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 EXTENDED COVERAGE LINER, GROUP 2, 32MM I.D., REF 142-32-62, 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. DIAGNOSIS THAT LED TO IMPLANTATION: PRIMARY COXARTHROSIS.

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

  MAUDE report 18319002 ↗
• InjuryOct 18, 2023Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED HIMSELF FOR A CHECK-UP OF THE DEVICE IMPLANTED IN 2018 HIP PROSTHESIS. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC BASE AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF PREMATURE INLAY WEAR. THIS COULD HAPPEN. REVISION CAN BE VERIFIED WITH CUP REPLACEMENT (MRS TITAN MAX 56 MM). AS PART OF THE REPLACEMENT OPERATION. THE CURETTAGE AND FILLING OF THE CYSTS IN THE ACETABULUM WAS CARRIED OUT USING ALLOGENEIC SPONGIOSA AND THE REPLACEMENT OF THE CYSTS PROSTHETIC HEAD. ITEM DATA OF THE IMPLANTATION AND REPLACEMENT, AS WELL AS PHOTOS OF THE EXPLANTS, WILL BE SENT UPON RECEIPT. THE EXPLANTS ARE CURRENTLY IN THE LABORATORY DOCTOR'S OFFICE FOR MICROBIOLOGICAL EXAMINATION USING SONICATION. AFTER THE EXAMINATION (14 DAYS OF LONG-TERM INCUBATION), THESE WILL BE SENT BACK TO THE CUSTOMER AND WILL BE MADE AVAILABLE IF THE CUSTOMER PROVIDES CONSENT. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 17958726 ↗
• InjurySep 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN INSPECTION OF THE HIP PROSTHESIS IMPLANTED IN 2019. 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. THIS COULD BE VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6), 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE +5MM LATERALIZED LINER GROUP 2, 36MM ID REF 146-36-52, SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO REPLACING THE INLAY, THE FIRM INTEGRITY OF THE SOCKET WAS DETERMINED, THE CYSTS IN THE SOCKET WERE CURED AND SEALED USING ALLOGENEIC SPONGIOSA, AND THE HEAD OF THE PROSTHESIS WAS REPLACED. THE EXPLANTS ARE CURRENTLY IN THE LABORATORY PRACTICE IN OSNABRUCK (ROSTOCKER STR. 5-7, 49124 GEORGSMARIENHUTTE, TEL.: 05401-33910) FOR MICROBIOLOGICAL EXAMINATION USING SONICATION.

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

  MAUDE report 17816711 ↗
• InjurySep 20, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE GERMAN COMPETENT AUTHORITIES INDICATES THAT AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED FOR A CHECK ON THE HIP PROSTHESIS IMPLANTED IN 2015. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY COARSE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS COULD BE VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6), 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO REPLACING THE INLAY, THE FIRM ACETABULAR INTEGRITY WAS DETERMINED, THE CYSTS IN THE ACETABULUM WERE TREATED AND SEALED USING ALLOGENEIC SPONGIOSA, AND THE PROSTHESIS HEAD WAS REPLACED. THE EXPLANTS ARE CURRENTLY IN THE HOSPITAL'S LABORATORY FOR MICROBIOLOGICAL EXAMINATION USING SONICATION. AFTER COMPLETION OF THE EXAMINATION (14 DAYS LONG-TERM INCUBATION), THESE ARE MADE AVAILABLE TO THE MANUFACTURER ON REQUEST FOR FURTHER MATERIAL-TECHNICAL EXAMINATION. SURGICAL REPORTS/X-RAYS ARE ALSO MADE AVAILABLE ON REQUEST; HOWEVER, PENDING PATIENT'S CONSENT.

  Patient problems: Failure of Implant

  MAUDE report 17786263 ↗
• InjurySep 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY GERMANY (BFARM# 25519/23) COMPETENT AUTHORITIES, AS PART OF THE EXACTECH COMPANY'S RECALL CAMPAIGN, THE PATIENT PRESENTED HIMSELF DURING OUR CONSULTATION HOURS FOR A FOLLOW-UP CHECK. THERE WERE COMPLAINTS FROM THE ARTIFICIAL HIP JOINT IMPLANTED IN 2018 ON THE RIGHT. A RADIOLOGICAL CHECK WAS CARRIED OUT. THERE WAS A SIGNIFICANT DECENTERING OF THE HEAD IN THE INLAY WITH OSTEOLYSIS OF THE SOCKET INTERFACE AS A SIGN OF SIGNIFICANT WEAR OF THE INLAY. THIS COULD BE VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (REF: 146-36-52, SN: (B)(6). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO REPLACING THE INLAY, THE INTEGRITY OF THE SOCKET WAS DETERMINED, THE CYSTS IN THE SOCKET WERE CURED AND SEALED USING ALLOGENEIC SPONGIOSA, AND THE PROSTHESIS HEAD WAS REPLACED. UNFORTUNATELY, THE EXPLANTS WERE NOT PHOTOGRAPHED AND ARE CURRENTLY BEING MICROBIOLOGICALLY EXAMINED AT THE LABORATORY DOCTOR'S OFFICE. AFTER COMPLETION OF THE EXAMINATION, THESE ARE SENT BACK TO MANUFACTURER FOR EXAMINATION. OTHER FINDINGS/X-RAY IMAGES/SURGICAL REPORTS ARE ALSO MADE AVAILABLE IF THERE IS A RELEASE FROM THE MEDICAL CONFIDENTIALITY OBLIGATION.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17751415 ↗
• InjurySep 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, A RADIOLOGICAL CHECK WAS CARRIED OUT AND THERE WAS A CONSIDERABLE DECENTERING OF THE HEAD IN THE INLAY, WITH OSTEOLYSIS OF THE SOCKET INTERFACE AS A SIGN OF CLEAR WEAR OF THE INLAY WAS IMPRESSIVE. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2023. IN ADDITION TO REPLACING THE INLAY, THE INTEGRITY OF THE ACETABULUM WAS DETERMINED AND CYSTS IN THE ACETABULUM WERE CURED AND SEALED. INDICATION FOR IMPLANTATION: POST-TRAUMATIC COXARTHROSIS.

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

  MAUDE report 17690172 ↗
• InjuryAug 31, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION OUS, THAT A PATIENT HAD AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2016. THE PATIENT WENT TO AN INPATIENT REHABILITATION AT THE REHABILITATION CENTER FOR ORTHOPEDIC REHABILITATION FOR AN UNKNOWN AMOUNT OF TIME. EXAMINATIONS ON (B)(6) 2023 SHOWED AN IMMEDIATE NEED FOR REVISION. ¿SUBSEQUENT EXAMINATIONS CONFIRMED THE SUSPICION THAT THE IMPLANT FROM YOUR COMPANY SHOWED CONSIDERABLE WEAR, WHICH IS WHY THE ATTENDING PHYSICIANS DETERMINED THAT AN IMMEDIATE REVISION WAS NECESSARY.¿ SINCE THE END OF 2019, THE PATIENT HAS BEEN SUFFERING FROM INCREASING BACK PAIN AFTER STANDING AND SITTING FOR A LONG TIME AND RECENTLY ALSO WITH SUDDEN PAIN SYMPTOMS IN BOTH HIP JOINTS (ELECTRIC SHOCKS). THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 17663102 ↗
• InjuryMay 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL THA, PATIENT HAD A REVISION DUE TO POLYETHYLENE WEAR. PATIENT WAS REVISED TO A CC INLAY VITAMIN E, LIPPE Ø 32, GR. 2 (CAT# 142-32-62 / SERIAL# (B)(6)). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17019630 ↗
• InjuryJun 1, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S CT AND X-RAY IMAGES FROM 2019 ALREADY SHOW AN ASYMMETRICAL POSITION OF BOTH PROSTHESIS HEADS. THE IMAGES WERE TAKEN DUE TO A DISC/LUMBAR SPINE PROBLEM. THE PATIENT CAME IN FOR A CHECK-UP IN 2021 WITH MILD DISCOMFORT IN BOTH HIP JOINTS. THE X-RAY SHOWED THE ALREADY KNOWN DECENTRATION OF THE PROSTHESIS HEADS AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM ON THE RIGHT AS A SIGN OF INLAY WEAR. THE REVISION OF THE RIGHT SIDE WITH THE INLAY BEING CHANGED TO A VITE-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, +5MM LATERALIZED LINER, GROUP 2, 36MM I.D. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM SOCKET INTEGRITY WAS DETERMINED, THE CYSTS IN THE SOCKET WERE CURED AND FILLED USING CERAMENT BONE FILLER, AND THE PROSTHESIS HEAD WAS REPLACED.

  Patient problems: Discomfort; Failure of Implant; Insufficient Information; Osteolysis

  MAUDE report 11916222 ↗
• InjuryApr 27, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THE RADIOLOGICAL FINDINGS OF THE PATIENTS TREATED WITH THIS IMPLANT WERE CHECKED. AN INCREASED DECENTERING OF THE HEAD IN THE INLAY FOR 5 YEARS AFTER IMPLANTATION AND PRONOUNCED OSTEOLYSIS IN THE BONY INTERFACE OF THE METAL SOCKET WERE EVIDENT AS SIGNS OF SIGNIFICANT INLAY WEAR.

  Patient problems: Failure of Implant

  MAUDE report 11731355 ↗
• InjuryApr 26, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 4 MONTHS POST INITIAL TOTAL HIP ARTHROPLASTY (THA) ON BOTH SIDES, THE PATIENT UNDERWENT REVISION OF THE LEFT SIDE THA. THE RIGHT SIDE WAS LATER REVISED AS WELL. CT AND X-RAY IMAGES HAD ALREADY SHOWN AN ASYMMETRICAL POSITION OF BOTH PROSTHESIS HEADS. THE IMAGES WERE TAKEN DUE TO A DISC/LUMBAR SPINE PROBLEM. THE PATIENT CAME IN FOR A CHECK-UP WITH MILD DISCOMFORT IN BOTH HIP JOINTS. THE X-RAY SHOWED THE ALREADY KNOWN DECENTRATION OF THE PROSTHESIS HEADS AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM LEFT>RIGHT AS A SIGN OF INLAY WEAR. NO FURTHER INFORMATION IS AVAILABLE. REFER TO MANUFACTURER REPORT 1038671-2021-00263 FOR REVISION OF RIGHT SIDE.

  Patient problems: Discomfort; Failure of Implant; Osteolysis

  MAUDE report 11729745 ↗

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-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-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-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-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-2117-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,
• 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-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-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-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-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-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
• 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