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Novation 132-32-51Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Novation (184)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Exactech Novation hip implant is an uncemented metal-and-polymer hip replacement. Reports mostly describe premature wear of the plastic liner, implant failure, pain, bone loss, and revision surgery. There are 26 reports, including 26 injuries and no deaths. There are 2 open recalls: one concerns packaging that may contribute to accelerated wear, and the other concerns edge-loading and premature wear in certain implant configurations and surgical positioning.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
26
Deaths reported
0
Injuries reported
26
Recalls naming it
2

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885862207029), received between Dec 19, 2019 and Apr 21, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Naturally Worn” (22 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K121392); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 4 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

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-1732-2022 · 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-2133-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Naturally Worn22
  • Adverse Event Without Identified Device or Use Problem6
  • Insufficient Device Problem Information5
  • Fracture2
  • Appropriate Device Problem Term/Code Not Available1
  • Flaked1

Patient problems

  • Failure of Implant13
  • Insufficient Information9
  • Osteolysis8
  • Pain8
  • Synovitis3
  • Ambulation or Postural Difficulties2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Aseptic loosening1

Recent adverse event reports

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

  • InjuryApr 21, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 24943911 ↗
  • InjuryMar 24, 2026Naturally Worn

    IT WAS REPORTED A PATIENT, WHO HAD A LEFT THA, REPORTED EARLY WEAR OF PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE AND WAS ADMITTED TO THE HOSPITAL AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

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

    MAUDE report 24682412 ↗
  • InjuryMay 8, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A 68 YO FEMALE PATIENT, WHO HAD A LEFT HIP IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE TOTAL HIP DUE TO PREMATURE POLYETHELENE WEAR OF THE RECALLED GXL LINER. THEY WERE REVISED TO A NEW LINER, HEAD, AND ADAPTOR. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE PATIENT¿S LEGAL TEAM REQUESTED THE PRODUCT. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 21989686 ↗
  • InjurySep 27, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS PATIENT WAS WAS REVISED APPROXIMATELY 6 YEARS 7 MONTHS POST OP. THE PATIENT PRESENTED TO SURGEONS OFFICE WITH POLY WEAR SHOWN ON X-RAY AND A RECALLED IMPLANT. THE PATIENT HAD AN ACETABULAR POLY LINER AND FEMORAL HEAD SWAP. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT LEFT THE OR STABLE.

    Patient problems: Insufficient Information

    MAUDE report 20320784 ↗
  • InjuryAug 14, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING IN BODY AND MIND; ADDITIONAL SURGERIES, PAIN, LOSS OF A NORMAL LIFE, AND LOSS OF INCOME; MEDICAL CARE IN THE PAST AND FUTURE; UNABLE TO ATTEND TO HER NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME; SUBSTANTIAL LOSS OF INCOME. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Synovitis

    MAUDE report 19983633 ↗
  • InjuryJul 25, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR UNKNOWN ISSUES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Patient problems: Insufficient Information

    MAUDE report 19833444 ↗
  • InjuryJun 30, 2024Fracture; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Fracture; Naturally Worn; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THIS 68 Y/O FEMALE PATIENT'S RIGHT HIP WAS REVISED FROM A GXL LINER TO AN XLE LINER AND A BIOLOX HEAD AND SLEEVE. DUE TO LYSIS RECALL. THE PATIENT WAS REVISED TO A COMPETITOR'S LINER AND A + 32 BIOLOX HEAD +3.5 SLEEVE. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE PATIENT WANTS TO KEEP THE DEVICE.

    Patient problems: Osteolysis

    MAUDE report 19641013 ↗
  • InjuryJun 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A NOVATION GXL DEVICE ON THE RIGHT HIP AND THEN APPROXIMATELY 4 YEARS, 4 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

    MAUDE report 19594909 ↗
  • InjuryJun 20, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 105 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 19573840 ↗
  • InjuryJun 19, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL LEFT HIP IMPLANTED IN SEPTEMBER OF 2016, UNDERWENT A REVISION PROCEDURE. THE SURGEON REVISED THE HEAD AND LINER DUE TO A RECALLED GXL LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS ARE AVAILABLE. LEGAL INDICATED. DEVICE IMAGES WERE PROVIDED. NO X-RAYS WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 19566842 ↗
  • InjuryMay 8, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 63 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, AND INABILITY TO LIFT HER LEG. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant; Insufficient Information; Loss of Range of Motion; Pain

    MAUDE report 19268347 ↗
  • InjuryOct 29, 2023Naturally Worn; Naturally Worn

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO RECALL OF THE GXL LINER. THE LINER AND HEAD WERE REMOVED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 18027236 ↗
  • InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    AS REPORTED VIA MEDWATCH REPORT (REF# MW5119893) , APPROXIMATELY NINE MONTHS POST INITIAL THA, THE PATIENT HAD A REVISION OF RECALLED NOVATION PLASTIC LINER AND CUP IMPLANTS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 17664746 ↗
  • InjuryAug 4, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT HIP REPLACEMENT SURGERY ON (B)(6) 2015. THEY HAD LEFT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 4 YEARS 4 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2020 OP REPORT POSTOPERATIVE DIAGNOSIS: LOOSE LEFT TOTAL HIP SOCKET WITH MARKED OSTEOLYSIS. THE STEM WAS CONFIRMED TO BE WELL FIXED WITH NO EVIDENCE OF LOOSENING OR SIGNIFICANT LYSIS PROXIMALLY. THE SOCKET WAS GROSSLY LOOSE. THE SURGEON NOTED IT WAS REMOVED EASILY AND THERE WAS MARKED OSTEOLYSIS WITH DESTRUCTIVE CHANGES INFERIORLY AND POSTERIORLY AS WELL AS SOME ANTERIOR LYTIC CHANGE AS WELL. POSTEROSUPERIORLY, THERE WAS SOME BONE AND SUPERIORLY BONE STOCK WAS GOOD AS WAS THE ANTEROSUPERIOR BONE STOCK. THE PATIENT WAS AWOKEN AND TRANSFERRED OUT OF THE OPERATING ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Inadequate Osseointegration; Osteolysis

    MAUDE report 17462688 ↗
  • InjuryJul 25, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, THE PATIENT HAD AN INITIAL THA ON (B)(6) 2019. THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN IN THE RIGHT HIP. THE PATIENT WAS IMPLANTED WITH A NOVATION GXL HIP LINER THAT IS NOW RECALLED. THE PATIENT UNDERWENT A TOTAL HIP REVISION ON (B)(6) 2023. THE EXACTECH FEMORAL HEAD, EXACTECH NOVATION CROWN CUP AND THE LINER WERE REMOVED FROM THE PATIENT. THE PATIENT WAS RE-IMPLANTED WITH A COMPETITOR PRODUCT TO THEIR ACETABULUM AND AN EXACTECH BIOLOX DELTA OPTION HEAD AND SLEEVE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE, AND A 15-30 MINUTE SURGICAL DELAY/PROLONGATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION.

    Patient problems: Failure of Implant; Osteolysis; Pain

    MAUDE report 17393967 ↗
  • InjuryJul 12, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2017. THE PATIENT WAS REVISED TO A FACE CHANGING LATERALIZED 32 MM LINER AND A +7 ADAPTER 32 HEAD ON (B)(6) 2023. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 17313455 ↗
  • InjuryApr 17, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED, THE FEMALE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2015. THE PATIENT UNDERWENT PAINFUL AND RISKY REVISION SURGERY ON (B)(6)-2023 TO REMOVE THE GXL LINER. THE PATIENT HAD ENDURED AND CONTINUES TO ENDURE A PAINFUL RECOVERY AND REHABILITATION PROCESS FROM HER REVISION SURGERY. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Failure of Implant; Implant Pain; Osteolysis

    MAUDE report 16751128 ↗
  • InjuryNov 30, 2022Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP THE INITIAL THA, THIS 84 Y/O FEMALE PATIENT WAS REVISED DUE TO PAIN. SURGEON FOUND SYNOVITIS AND WEAR ON POLY. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS UNAVAILABLE. NO OTHER INFORMATION AVAILABLE.

    Patient problems: Failure of Implant; Pain; Synovitis

    MAUDE report 15885307 ↗
  • InjuryNov 29, 2022Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL THA, PATIENT WAS REVISED DUE TO PAIN AND WEAR PER SURGEON. PATIENT WAS REVISED WITH SAME SIZES BUT WITH VIT E POLY. THERE WAS NO BREAKAGE OR SURGERY DELAY WAS NOTED. PATIENT HAD GOOD RANGE OF MOTION (ROM) AND STABILITY. PATIENT LEFT IN STABLE CONDITION. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Failure of Implant; Pain

    MAUDE report 15877690 ↗
  • InjuryOct 11, 2022Naturally Worn; Naturally Worn

    AS REPORTED, THE PATIENT HAD AN INITIAL THA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO POLY WEAR AND MASSIVE OSTEOLYSIS IN THE ACETABULUM AND PROXIMAL FEMUR. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Aseptic loosening; Failure of Implant; Osteolysis; Pain; Synovitis

    MAUDE report 15584739 ↗
  • InjurySep 2, 2022Flaked; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Flaked; Naturally Worn; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO PAIN. THE SURGEON REPLACED THE GXL TO XLE AND ADAPTOR BIOLOX WITH HEAD. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Failure of Implant; Scar Tissue

    MAUDE report 15349089 ↗
  • InjuryJul 31, 2022Fracture; Naturally Worn; Insufficient Device Problem Information; Fracture; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED, THIS PATIENT HAD A THA ON (B)(6) 2017. ON (B)(6) 2022, THE PATIENT UNDERWENT A HIP REVISION. THE PATIENT LEFT IN STABLE CONDITION. NO OTHER KNOWN INFO.

    Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Pain

    MAUDE report 15136916 ↗
  • InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED BY LEGAL TEAM, APPROXIMATELY FOUR YEARS POST THA, THIS FEMALE PATIENT NEED A REVISION OF HET HIP. PATIENT DOES NOT HAVE A SCHEDULED REVISION SURGERY YET.

    Patient problems: Failure of Implant

    MAUDE report 13772016 ↗
  • InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED BY LEGAL TEAM, APPROXIMATELY ONE MONTH POST INITIAL THA, THIS FEMALE PATIENT HAD A REVISION DUE TO INFECTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: Bacterial Infection

    MAUDE report 13771813 ↗
  • InjuryMar 15, 2021Naturally Worn; Naturally Worn

    AS REPORTED, DURING A SCHEDULED REVISION CASE. APPROXIMATELY 5 YRS POST THE INITIAL LEFT THA IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT HAD A LEFT GXL LINER IN WITH SIGNIFICANT WEAR AND WAS SCHEDULED FOR REVISION. THE SURGEON TOOK OUT A GXL GROUP 1 32 LINER EXTENDED LINER AND 32+0 BIOLOX CERAMIC HEAD. SURGEON REPLACED WITH A XLE GROUP 1 32 EXTENDED LINER AND A +3.5-DELTA ADAPTER SLEEVE AND 32 +0 DELTA BIOLOGIC HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

    Patient problems: Failure of Implant

    MAUDE report 11488034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121392. One submission often covers many models, so check the product and lot details in each record.

  • Z-2119-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component
  • 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-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-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-2129-2021 · Jun 29, 2021 · Open, Classified
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant

Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices

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Sources and updates

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