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Novation 130-36-54Recalls & 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 hip prosthesis is a cemented metal-on-polyethylene hip implant used in total hip replacement. The 46 reports mostly describe gradual wearing of the plastic acetabular liner and the bone loss (osteolysis) that can follow, often leading to pain, joint inflammation and revision surgery years after implantation; 46 injuries and no deaths were reported. Two open recalls cover the same wear issue: one from August 2022, involving certain GXL liners packaged in non-conforming bags, and one from June 2021, about edge-loading and premature wear with certain implant configurations and 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
46
Deaths reported
0
Injuries reported
46
Recalls naming it
2

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10885862022240), received between Jul 12, 2020 and Mar 16, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Naturally Worn” (44 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 2 reportsMar 2024: 0 reportsApr 2024: 4 reportsMay 2024: 4 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 4 reportsSep 2024: 2 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 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: 0 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-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-2118-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Naturally Worn44
  • Adverse Event Without Identified Device or Use Problem7
  • Insufficient Device Problem Information7
  • Mechanical Problem3
  • Fracture1
  • Unstable1

Patient problems

  • Failure of Implant32
  • Osteolysis21
  • Pain15
  • Synovitis12
  • Insufficient Information11
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
  • Implant Pain8
  • Bursitis4

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 16, 2026Naturally Worn

    AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, ON THE RIGHT SIDE. 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 24604769 ↗
  • InjuryJun 13, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT THA. SUBSEQUENTLY, THE PATIENT PRESENTED TO THEIR SURGEON WITH COMPLAINTS OF PAIN, STIFFNESS AND DISSATISFACTION. AS A RESULT, APPROXIMATELY 10 YEARS AND 3 MONTHS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION. THE ACETABULAR LINER WAS NOTED TO BE WORN AND WAS EXCHANGED ALONG WITH THE FEMORAL HEAD. DURING SURGERY THE PATIENT WAS NOTED TO HAVE EXCESS SCAR TISSUE, SYNOVITIS AND ECTOPIC BONE GROWTH. NO FURTHER PATIENT IMPACT REPORTED.

    Patient problems: Extraskeletal ossification; Pain; Scar Tissue; Synovitis; Unspecified Musculoskeletal problem

    MAUDE report 22205108 ↗
  • InjuryMar 17, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT HIP WAS REVISED. SURGEON PERFORMED A POLY SWAP THAT WAS SECONDARY TO WEAR AND OSTEOLYSIS. PATIENT WAS CONVERTED TO 40MM XLE LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Osteolysis

    MAUDE report 21627509 ↗
  • InjuryOct 8, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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: Bursitis; Osteolysis

    MAUDE report 20397224 ↗
  • InjuryOct 8, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Bursitis; Osteolysis; Synovitis

    MAUDE report 20396836 ↗
  • InjurySep 18, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, POLY WEAR SYNOVITIS, OSTEOLYSIS, LOOSE ACETABULAR COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Osteolysis; Pain; Scar Tissue; Synovitis

    MAUDE report 20246795 ↗
  • InjurySep 16, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 137 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PHYSICAL PAIN AND SUFFERING, MENTAL ANGUISH AND EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

    MAUDE report 20229204 ↗
  • InjuryAug 26, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER A RIGHT 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 20064267 ↗
  • InjuryAug 21, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 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 20020596 ↗
  • InjuryAug 15, 2024Naturally Worn; Naturally Worn

    LEGAL CASE - USA (MASTER CASE. (B)(6)). CASE NO. (B)(6). PATIENT ID: (B)(6). RELATED CASE: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 19993046 ↗
  • InjuryAug 13, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 19972202 ↗
  • InjuryJun 3, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED.

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

    MAUDE report 19454680 ↗
  • InjuryJun 3, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 66 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PATIENT DEVELOPED INCREASING PAIN OF THE RIGHT HIP. DURING THE PROCEDURE THE ACETABULAR LINER WAS FOUND TO BE WORN. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS REPORTED POLYETHYLENE LINER WEAR WITH ASSOCIATED SYNOVITIS AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

    MAUDE report 19453531 ↗
  • InjuryMay 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SCARRING, AND OSTEOLYSIS. INITIAL SURGERY AND 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: Failure of Implant; Implant Pain; Osteolysis; Scar Tissue

    MAUDE report 19391718 ↗
  • InjuryMay 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 104 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant; Implant Pain; Osteolysis; Scar Tissue; Synovitis

    MAUDE report 19390530 ↗
  • InjuryMay 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BILATERAL HIP PAIN, AND PERIPROSTHETIC OSTEOLYSIS. 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: Failure of Implant; Implant Pain; Osteolysis

    MAUDE report 19390401 ↗
  • InjuryMay 8, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT HIP ARTHROPLASTY ON (B)(6) 2014, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 9 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

    MAUDE report 19273449 ↗
  • InjuryApr 29, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2013 AND THEN WAS REVISED ON (B)(6) 2024. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO JOINT PAIN, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, REVISION SURGERY, AND OTHER INJURIES PRESENTLY UNDIAGNOSED WHICH WILL REQUIRE ON GOING MEDICAL CARE. 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: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Failure of Implant; Loss of Range of Motion; Osteolysis; Pain

    MAUDE report 19201489 ↗
  • InjuryApr 26, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6)2013 AND THEN WAS REVISED ON (B)(6)2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO JOINT PAIN, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, REVISION SURGERY, AND OTHER INJURIES PRESENTLY UNDIAGNOSED WHICH WILL REQUIRE ON GOING MEDICAL CARE. 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: Anxiety; Distress; Failure of Implant; Implant Pain; Loss of Range of Motion; Osteolysis

    MAUDE report 19197754 ↗
  • InjuryApr 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

    MAUDE report 19170986 ↗
  • InjuryApr 11, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2016, WITH A PLANNED REVISION, AS OF (B)(6) 2024 THE REVISION DATE AND SURGICAL INFORMATION HAVE NOT BEEN RECEIVED. SCHEDULED DATE FOR REVISION WAS REPORTED TO BE (B)(6) 2023. THERE IS NO OTHER INFORMATION PROVIDED/AVAILABLE.

    Patient problems: Insufficient Information; Osteolysis

    MAUDE report 19089286 ↗
  • InjuryFeb 19, 2024Naturally Worn; Naturally Worn

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 7 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: FAILED LEFT TOTAL HIP. REMOVED A LOT OF ADVERSE INFLAMED REACTIVE TISSUE.

    Patient problems: Failure of Implant

    MAUDE report 18730361 ↗
  • InjuryFeb 19, 2024Naturally Worn; Naturally Worn

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON 7 MAR 2023 DIAGNOSIS: FAILED RIGHT HIP REPLACEMENT THE SURGEON COULD EASILY SEE A FAIRLY LARGE PSEUDOTUMOR EMERGING FROM THE JOINT AND EXTENDING UP INTO THE WATSON-JONES INTERVAL. IT WAS A BROWN, LIGHT-BROWNISH, GRAY BLAND APPEARING SEPSIS, HAD A TYPICAL APPEARANCE OF A PSEUDOTUMOR.

    Patient problems: Failure of Implant; Implant Pain

    MAUDE report 18730241 ↗
  • InjuryJan 23, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014 AND THEN EXPERIENCED A SURGICAL REVISION APPROXIMATELY 9 YEARS, 2 MONTHS LATER ON (B)(6) 2024. THE PATIENT HAD A RECALLED HIP LINER. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO OTHER INFORMATION AVAILABLE.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 18563758 ↗
  • InjuryJan 8, 2024Naturally Worn; Naturally Worn

    AS REPORTED BY THE GERMANY COMPETENT AUTHORITIES AND AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE MALE PATIENT PRESENTED HIMSELF FOR A CHECK-UP OF THE DEVICE IMPLANTED IN 2012 HIP PROSTHESIS ON THE RIGHT. 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. IN THE SUPPLEMENTARY CT EXAMINATION ALSO REVEALED PARTIAL CORTICAL DESTRUCTION OF THE INNER WALL OF THE PELVIS. DURING THE AUDIT SURGERY ON (B)(6) 2023, PATIENT REQUIRED A SOCKET CHANGE TO COMPETITOR¿S DEVICES. AS PART OF THE REPLACEMENT OPERATION, THE CURETTAGE AND FILLING OF THE CYST IN THE SOCKET USING ALLOGENEIC SPONGIOSA AND THE REPLACEMENT OF THE PROSTHETIC HEAD. THE EXPLANTS ARE CURRENTLY IN THE LABORATORY DOCTOR'S OFFICE FOR MICROBIOLOGICAL EXAMINATION USING SONICATION.

    Patient problems: Bone Fracture(s); Failure of Implant; Osteolysis

    MAUDE report 18468442 ↗

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

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