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Novation 130-36-52Recalls & 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 prosthesis has 124 adverse event reports, with no deaths and 123 injuries. Most reports describe early wear of the plastic liner that releases tiny particles into the body, along with pain, bone loss and implant failure, and some patients needed further surgery. Two open recalls name this device: one covers liners in non-conforming bags that may speed up wear, and one covers edge contact that may cause early wear in certain patients.

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
124
Deaths reported
0
Injuries reported
123
Recalls naming it
2

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10885862207081), received between Oct 7, 2019 and Jun 9, 2026 — classified as 123 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (109 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: 1 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 5 reportsApr 2024: 5 reportsMay 2024: 10 reportsJun 2024: 6 reportsJul 2024: 2 reportsAug 2024: 4 reportsSep 2024: 4 reportsOct 2024: 3 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 2 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: 1 reportsMar 2026: 7 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202610
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-2118-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Naturally Worn109
  • Insufficient Device Problem Information24
  • Adverse Event Without Identified Device or Use Problem19
  • Unstable4
  • Appropriate Device Problem Term/Code Not Available2
  • Fracture2
  • Flaked1
  • Material Erosion1

Patient problems

  • Failure of Implant65
  • Pain48
  • Osteolysis45
  • Insufficient Information41
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available20
  • Implant Pain17
  • Swelling/ Edema12
  • Synovitis10

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 9, 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: Osteolysis

    MAUDE report 25451140 ↗
  • InjuryMar 24, 2026Naturally Worn

    IT WAS REPORTED A PATIENT, WHO HAD A 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: Insufficient Information

    MAUDE report 24678515 ↗
  • InjuryMar 24, 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 24674846 ↗
  • InjuryMar 19, 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 24643075 ↗
  • 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 24611655 ↗
  • 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 24603883 ↗
  • 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; Osteolysis

    MAUDE report 24603786 ↗
  • InjuryMar 16, 2026Naturally Worn

    ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT WAS REVISED.

    Patient problems: Insufficient Information; Osteolysis

    MAUDE report 24603442 ↗
  • InjuryFeb 2, 2026Fracture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED THAT THE POLY LINER IN BREAKING APART. AS A RESULT, THE PATIENT REPORTED THE NEED FOR A REVISION SURGERY ON A FUTURE DATE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 24234792 ↗
  • InjuryJun 30, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT, WHO HAS LEFT SIDE HIP IMPLANTS, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH POLY WEAR, WHICH WAS SHOWN ON AN X-RAY, AND A RECALLED IMPLANT. THE PATIENT HAD AN ACETABULAR POLY LINER AND FEMORAL HEAD SWAP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE AS THEY WERE DISPOSED OF BY THE CUSTOMER. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Patient problems: Pain

    MAUDE report 22358656 ↗
  • InjuryMar 17, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A 72 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH POLY WEAR, WHICH WAS SHOWN ON AN X-RAY, AND A RECALLED IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION OF THE RIGHT HIP. THE PATIENT HAD AN ACETABULAR POLY LINER AND FEMORAL HEAD SWAP. 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. THEY WERE DISCARDED BY THE HOSPITAL. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 21625645 ↗
  • MalfunctionMar 4, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT REPORTED "HAVING ISSUES" AND THAT THEIR SURGEON CONFIRMED THE PRESENCE OF PARTICLE DISEASE. DETAILS REGARDING THE ORIGIN AND NATURE OF THE PARTICULATE DEBRIS AND THE MANIFESTATION(S) OF THE PARTICLE DISEASE IN THE PATIENT WERE NOT PROVIDED. AT THE TIME OF REPORTING, NO MEDICAL INTERVENTION HAS BEEN INDICATED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: Insufficient Information; Local Reaction

    MAUDE report 21516082 ↗
  • InjuryJan 14, 2025Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 7 YEARS AND 1 MONTH POST INITIAL RIGHT TOTAL HIP ARTHROPLASTY (THA), REVISION WAS PERFORMED DUE TO COMPLAINTS OF PAIN. THE RECALLED LINER WAS REVISED. THE EVENT WAS UNRELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Pain

    MAUDE report 21150360 ↗
  • InjuryOct 21, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 12 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 20499708 ↗
  • InjuryOct 8, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 85 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

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

    MAUDE report 20402101 ↗
  • InjuryOct 7, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

    Patient problems: Implant Pain; Osteolysis; Synovitis

    MAUDE report 20390253 ↗
  • InjurySep 17, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ USA (MDL NO. 3044) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DEBILITATING INJURIES AND DAMAGES, SIGNIFICANT PAIN AND SCARRING, SWELLING, EFFUSION, INFLAMMATION, DIFFICULTY WALKING, ANTALGIC GAIT, TISSUE DESTRUCTION, BONE DESTRUCTION, LOSS OF MOBILITY AND OTHER INJURIES PRESENTLY UNDIAGNOSED, ANXIETY AND EMOTIONAL DISTRESS A DIRECT RESULT OF THE INJURIES CAUSED BY EXACTECH DEVICE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

    Patient problems: Emotional Changes; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

    MAUDE report 20240002 ↗
  • InjurySep 10, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 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 20179736 ↗
  • InjurySep 5, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO PROSTHESIS WEAR, DISCOMFORT AND SCAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Discomfort; Scar Tissue

    MAUDE report 20146055 ↗
  • InjurySep 4, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PLAINTIFF, AVERY KNIGHT, SUFFERED FROM PAIN, SWELLING, LIMTITED MOTION AND HAD VARIOUS PROCEDURES DONE ON HIS LEFT HIP AS A REMEDY TO FIX THE DAMAGE INFLICTED FROM THE IMPLANTED EXACTECH DEVICE. THE IMPLANTATION OF THE EXACTECH DEVICE AND REVISION HAS CAUSED PLAINTIFF, AVERY KNIGHT, SERIOUS PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, PHYSICAL DISABILITY, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES, AND HE WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. ACCORDINGLY, PLAINTIFF IS SEEKING COMPENSATORY AND SPECIAL DAMAGES INCLUDING ATTORNEY'S FEES AND COSTS AND ALL OTHER AVAILABLE REMEDIES UNDER THE LAW. PLAINTIFF SHARON KNIGHT HAS AND WILL CONTINUE TO SUFFER LOSS OF CONSORTIUM, COMPANIONSHIP, AND LOSS OF SERVICES, WHICH WILL BE PERMANENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO A

    Patient problems: Emotional Changes; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

    MAUDE report 20134068 ↗
  • InjuryAug 26, 2024Naturally Worn; Naturally Worn

    LEGAL CASE - USA. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Synovitis

    MAUDE report 20071922 ↗
  • InjuryAug 26, 2024Naturally Worn; Naturally Worn

    LEGAL CASE - USA. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY UNKNOWN MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CAUSE MIGRATION, OSTEOLYSIS, LOOSENING, POLYETHYLENE DEGRADATION, POLYETHYLENE FRACTURE, AND POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Osteolysis; Pain

    MAUDE report 20071695 ↗
  • InjuryAug 21, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 73 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, 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: Discomfort; Osteolysis; Pain; Scar Tissue

    MAUDE report 20018686 ↗
  • InjuryAug 13, 2024Naturally Worn; Naturally Worn

    IT IS REPORTED VIA LEGAL DOCUMENTATION 07-AUG-2024 THAT THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. **ORIGINAL SUMMARY THIS PATIENT IS VERIFIED RIGHT HIP ON (B)(6) 2017 WITH (B)(6). SHE HAD REVISION RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2023 WITH (B)(6) (OP REPORT ATTACHED). PRE/POST OP DIAGNOSIS: FAILED RIGHT TOTAL HIP REPLACEMENT SECONDARY TO POLYETHYLENE WEAR FROM EXACTECH RECALL. INDICATION FOR SURGERY: PATIENT PRESENTS WITH BACK PAIN. CT SCAN NOTES POLYETHYLENE WEAR. OP NOTES: HIP IS BURRED INTO THE POLYETHYLENE. LINE REMOVED

    Patient problems: Failure of Implant; Pain

    MAUDE report 19973202 ↗
  • InjuryJul 16, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 68 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EXCESSIVE POLYEHTYLENE WEAR, DEGRADING/SHEDDING POLYETHYLENE DEBRIS. PAIN, OSTEOLYSIS, TISSUE DAMAGE. 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; Insufficient Information; Osteolysis; Pain

    MAUDE report 19749408 ↗

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-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-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
  • 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-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-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,

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Sources and updates

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