Novation 136-32-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10885862024275), received between Nov 4, 2019 and Aug 22, 2025 — classified as 43 injuries.

The most frequently reported specific device problem is “Naturally Worn” (36 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S HIP REPLACEMENT WAS REVISED. REASON FOR THE REVISION IS UNKNOWN. NO FURTHER INFORMATION AT THIS TIME.

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

  MAUDE report 22877259 ↗
• InjuryApr 28, 2025Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT PRESENTED FOR A FOLLOW-UP. X-RAY AND CT SCANS REVEALED SLIGHT DECENTRATION OF THE PROSTHETIC HEAD AND MINOR OSTEOLYSIS IN THE ACETABULUM, SIGNS OF INLAY WEAR. THIS WAS VERIFIED DURING AN INLAY EXCHANGE ON (B)(6) 2025, TO A SPECIALLY APPROVED, VIT E-CURED INLAY (NOVATION XLE +5 MM LATERALIZED LINER, GROUP 1, 32 MM ID, REF 146-32-51, SN (B)(6)). DURING THE EXCHANGE SURGERY, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE CUP WAS DETERMINED, AND THE CYSTS IN THE CUP BED WERE CURED AND SEALED USING HYDROXYAPATITE + CALCIUM (CERAMENT BONE VOID FILLER), AS WELL AS THE REPLACEMENT OF THE PROSTHETIC HEAD.

  Patient problems: Cyst(s); Osteolysis

  MAUDE report 21923183 ↗
• InjuryApr 23, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 7 YEARS AND 4 MONTHS AGO. THE PATIENT STARTED HAVING PAIN AND SQUEAKING, SO THE SURGEON REVISED THE LINER AND HEAD. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21890745 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD A HIP PROSTHESIS CUP IMPLANTED. AS THE PATIENT'S SYMPTOMS INCREASED, 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 INLAY WAS CHANGED TO A SPECIALLY APPROVED INLAY. 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 BONE VOID FILLER, AND THE PROSTHESIS HEAD WAS CHANGED.

  Patient problems: Cyst(s); Osteolysis

  MAUDE report 21034380 ↗
• InjuryDec 13, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 11 YEARS AND 9 MONTHS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT CAME IN FOR A CHECK UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD, AND OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS EXCHANGED. 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, AND THE PROSTHESIS HEAD WAS CHANGED.

  Patient problems: Cyst(s); Osteolysis

  MAUDE report 20932043 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT HAD A HIP REVISION. THE X-RAY AND CT SCAN SHOWED AN INCIPIENT DECENTRATION OF THE PROSTHESIS HEAD ON THE LEFT AND MINOR OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF PREMATURE INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2024 TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE EXTENDED COVERAGE LINER, GROUP 1. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE SOCKET WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE SOCKET USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE REPLACEMENT OF THE PROSTHESIS HEAD.

  Patient problems: Osteolysis

  MAUDE report 20883386 ↗
• InjuryDec 4, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 1 MONTH POST INITIAL TOTAL HIP ARTHROPLASTY (THA), AS PART OF THE MANUFACTURER RECALL, THE PATIENT PRESENTED FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. REVISION OF THE RIGHT HIP WAS PERFORMED AND INLAY WEAR WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A SPECIALLY APPROVED VIT E-HARDENED INLAY (NOVATION XLE +5 MM LATERALIZED LINER, GROUP 1, 32 MM I.D., REF 146-32-51, SN (B)(6) . 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 (CERAMENT BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. PLEASE REFER TO REPORT # 1038671-2024-00383 FOR LEFT HIP REVISION.

  Patient problems: Osteolysis

  MAUDE report 20845480 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, WORSENING PAIN AND LATERAL-SIDED PAIN, OSTEOLYSIS, POLYETHYLENE WEAR AND DEBRIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Scar Tissue

  MAUDE report 20039971 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  FOLLOW-UP EXAMINATIONS CONFIRMED THAT BOTH HIP JOINTS WERE AFFECTED: INITIAL DECOMPOSITION OF THE ACETABULAR INLAY AND VISIBLE MICROPARTICLES LED TO THE DECISION TO PERFORM CORRECTIVE SURGERY ON BOTH HIP JOINTS. DUE TO THE VISIBLE EXTENT OF DAMAGE, IT WAS DECIDED TO BEGIN WITH THE LEFT HIP AND THEN PERFORM THE CORRECTIVE SURGERY ON THE RIGHT HIP. SECOND CORRECTIVE SURGERY (RIGHT HIP) WAS SCHEDULED. THIS CORRECTIVE SURGERY WAS CANCELED BY PHONE. DURING A DOCTOR'S CONSULTATION IT WAS STATED, FURTHER PROBLEMS WITH PACKAGING, ANOTHER PRODUCT RECALL CANNOT BE RULED OUT, RISK AVOIDANCE ¿ NO CORRECTIVE SURGERY (RIGHT HIP) WAS PERFORMED. A SUITABLE IMPLANT WAS NOT AVAILABLE FOR THE CORRECTIVE SURGERY SCHEDULED IN (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 19716576 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19594144 ↗
• InjuryJun 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT WHO HAD AN INITIAL HIP IMPLANTED, DATE AND SIDE UNKNOWN, UNDERWENT A REVISION PROCEDURE IN WHICH THE LINER WAS REPLACED. REVISION IMPLANT: 146-32-51 CC INLAY VITAMIN E, LATERALISIERT, Ø 32, GR. 1 A579342. NO FURTHER INFORMATION KNOWN AT THIS TIME.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 19577100 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND MAY REQUIRE A FUTURE REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19514155 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 42 MONTHS AFTER A TOTAL HIP REPLACEMENT PROCEDURE, THE PLAINTIFF MAY REQUIRE A FUTURE REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE PLAINTIFF HAS ALSO REPORTED PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Failure of Implant; Osteolysis; Pain

  MAUDE report 19508803 ↗
• InjuryMay 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 67 Y/O FEMALE PATIENT'S HIP WAS REVISED APPROXIMATELY 6 YEARS 9 MONTHS POST OP INITIAL SURGERY. 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 CHANGING THE INLAY TO A VITD-HARDENED ONE. SPECIALLY APPROVED INLAY (NOVATION XLE +5MM LATERALIZED LINER, REF (B)(4), SN (B)(6)) CAN BE VERIFIED. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE SOLID INTEGRITY OF THE CUP WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC SPONGIOSA AND THE REPLACEMENT OF THE PROSTHETIC HEAD.

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

  MAUDE report 19246469 ↗
• InjuryMay 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT HAD HIP A PROSTHETIC SOCKETS FROM EXACTECH IMPLANTED APPROXIMATELY 8 YEARS POSTS OP. AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED HERSELF FOR A CHECK-UP. THE X-RAY AND CT CHECK SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD ON THE LEFT AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS COULD HAPPEN WHEN THE INLAY WAS CHANGED ON (B)(6) 2024 VITD-HARDENED SPECIAL APPROVED INLAY (NOVATION XLE +5MM LATERALIZED LINER, GROUP 1, 32MM I.D. AS PART OF THE REPLACEMENT OPERATION, THE INLAY WAS REPLACED, DETERMINATION OF THE SOLID CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE CUP BED USING ALLOGENEIC SPONGIOSA AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant

  MAUDE report 19246455 ↗
• InjuryApr 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2013 AND THEN WAS REVISED ON (B)(6) 2023. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR, COMPONENT LOOSENING, DEVICE FAILURE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19167667 ↗
• InjuryMar 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN APPROXIMATELY 66 YO FEMALE PATIENT, INITIAL HIP IMPLANTED, ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 9 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. 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. THE INLAY WAS CHANGED TO A VITD-HARDENED ONE ON (B)(6) 2024, SPECIALLY APPROVED INLAY (NOVATION XLE, +5MM LATERALIZED LINER, GROUP 1, 32 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 CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD. DIAGNOSIS THAT LED TO IMPLANTATION: PRIMARY COXARTHROSIS M16.1 IMPLANTING CLINIC: BWKRHS WESTERSTEDE. ITEM DATA OF THE IMPLANTATION AND REPLACEMENT, AS WELL AS PHOTOS OF THE EXPLANTS, WILL BE SENT UPON CONFIRMATION OF RECEIPT WITH BFARM CASE NUMBER SUBMITTED LATER. THE EXPLANTS ARE CURRENTLY IN THE LABORATORY DOCTOR'S OFFICE FOR MI

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18852733 ↗
• InjuryMar 4, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL THA, THE 77 Y/O FEMALE PATIENT HAD REVISION DUE TO POLYETHYLENE WEAR. THE PATIENT WAS REVISED TO A CC INLAY VITAMIN E, LATERALISE, Ø 32, GR. 1 (CAT# 146-32-51 / SERIAL# (B)(6) NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18831207 ↗
• InjuryDec 12, 2023Naturally Worn; Naturally Worn

  THE 84 Y/O FEMALE PATIENT HAD PERSISTENT PAIN ON HER LEFT SIDE IN 2013 IMPLANTED HIP PROSTHESIS AFTER A FALL. THERE WAS A FRACTURE OF THE ACETABULUM. THE INLAY WEAR WAS CHECKED ALREADY DIAGNOSED AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN. SUSPECTS ALSO EMERGED HERE. CHANGES NOTED IN THE ACETABULUM AS A SIGN OF POSSIBLE OSTEOLYSIS. THE PATIENT DID NOT WANT TO HAVE THE PROCEDURE DONE ELECTIVELY OR FOR FURTHER DIAGNOSTICS. A REVISION SURGERY WAS NECESSARY DUE TO THE NOTED FRACTURE. A REVISION HIP CUP WITH TAB AND ILIAC PIN (COMPETITOR COMPANY) WAS IMPLANTED WITH FILLING OF THE OSTEOLYSIS WITH ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD. DIAGNOSIS THAT LED TO IMPLANTATION: PRIMARY COXARTHROSIS M16.1 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 ARE SENT BACK TO US AND THEN - A PRESENT ONE SUBJECT TO THE PATIENT'S CONSENT. SURGICAL REPORTS/X-RAYS ARE ALSO AVAILABLE UPON REQUEST.

  Patient problems: Failure of Implant; Hip Fracture; Implant Pain; Osteolysis

  MAUDE report 18310887 ↗
• InjuryNov 1, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY GERMAN COMPETENT AUTHORITIES, PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT WENT TO HAVE THE DEVICE IMPLANTED IN 2018 CHECKED 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. THE PATIENT WAS REVISED TO AN INLAY CHANGE ON (B)(6), 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE EXTENDED COVERAGE LINER, GROUP 1, REF (B)(4) SN (B)(6)). 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. AS PER INFORMATION RECEIVED THE ITEM DATA OF THE IMPLANTATION AND REPLACEMENT, AS WELL AS PHOTOS OF THE EXPLANTS, WILL BE SENT UPON RECEIPT. CONFIRMATION OF RECEIPT WITH BFARM CASE NUMBER SUBMITTED LATER. 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 ARE SENT BACK TO COMPETENT AUTHORITIES AND THEN A PRESENT ONE SUBJECT TO THE PATIENT'S CONSENT

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18051926 ↗
• InjuryOct 9, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 72 YO FEMALE PATIENT, INITIAL HIP IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED HERSELF IN 2019 WITH PAIN OF THEIR IMPLANTED HIP PROSTHESIS, THAT HAD EXISTED FOR SEVERAL MONTHS. THE X-RAY CONTROL SHOWED A CLEAR DECENTRATION OF THE PROSTHETIC SOCKET AND OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THE INLAY WAS CHANGED TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION, XLE EXTENDED COVERAGE LINER, GROUP 1, 32MM I.D. REF 142-32-61, SN (B)(6)), 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 THE PROSTHETIC HEAD WAS CHANGED. THE DEVICE WILL BE AVAILABLE FOR RETURN FOLLOWING MICROBIOLOGY EXAM BY THE CUSTOMER IF THE PATIENT GIVES CONSENT FOR THE RETURN. NO FURTHER INFORMATION.

  Patient problems: Osteolysis; Pain

  MAUDE report 17900415 ↗
• InjuryMay 15, 2023Detachment of Device or Device Component; Naturally Worn; Insufficient Device Problem Information; Detachment of Device or Device Component; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION DUE TO PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED THE PATIENT'S MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION SURGERY AND THE RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Metal Related Pathology; Pain; Synovitis

  MAUDE report 16929499 ↗
• InjuryMar 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THIS FEMALE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2014. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY AND FOR YEARS AFTER THE REPLACEMENT SURGERY, THE PATIENT'S RIGHT EXACTECH HIP DEVICE PERFORMED AS EXPECTED. THE PATIENT WAS REVISED ON (B)(6) 2020 DUE TO POLYETHYLENE LINER WEAR FAILURE RESULTING IN SIGNIFICANT TISSUE DAMAGE AND SYNOVITIS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Failure of Implant; Metal Related Pathology; Pain; Synovitis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16588374 ↗
• InjuryMar 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY A LEGAL NOTIFICATION, THIS FEMALE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2014. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY AND FOR YEARS AFTER THE REPLACEMENT SURGERY, THE PATIENT'S LEFT EXACTECH HIP DEVICE PERFORMED AS EXPECTED. THE PATIENT WAS REVISED ON (B)(6) 2020 DUE TO POLYETHYLENE LINER WEAR RESULTING IN SIGNIFICANT TISSUE DAMAGE AND SYNOVITIS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Failure of Implant; Metal Related Pathology; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16588348 ↗
• InjuryOct 5, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 60 YO FEMALE PATIENT, INITIAL IMPLANT OF THE LEFT KNEE ON (B)(6) 2016, WAS REVISED DUE TO EARLY GXL POLY WEAR ON (B)(6) 2022, APPROXIMATELY 5 YEARS 9 MONTHS POST THE INITIAL IMPLANT DATE. THEY WERE REVISED TO NOVATION XLE POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE AVAILABLE FOR RETURN.

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

  MAUDE report 15546265 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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