Novation 132-36-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10885862207036), received between Jan 28, 2022 and Apr 15, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Naturally Worn” (38 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 5 MONTHS POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT COMPLAINED OF HIP JOINT PAIN AND THE SURGEON DIAGNOSED WEAR OF THE INSERT. THE PATIENT WAS REVISED AND THE LINER WAS REPLACED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED LINER. THE SURGEON DECIDED TO ONLY REPLACED 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: Implant Pain

  MAUDE report 24888348 ↗
• InjurySep 8, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, STIFFNESS, AND DISSATISFACTION WITH THEIR LEFT TOTAL HIP REPLACEMENT. AS A RESULT, APPROXIMATELY SEVEN YEARS AND EIGHT MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 22991968 ↗
• InjuryMar 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN 80 YO MALE PATIENT, INITIAL LEFT HIP IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 6 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD SOME SHORTENING OF THE LEG AND SOME LINER POLY WEAR. BECAUSE THE PATIENT HAD A GXL LINER, THE SURGEON INDICATED IT WAS TIME TO EXCHANGE IT FOR AN XL LINER. THE PATIENT WAS REVISED TO A 36 FACE CHANGING LINER AND A +0 HEAD. 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 FOR RETURN. THE HOSPITAL WILL NOT RELEASE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Unequal Limb Length

  MAUDE report 21646545 ↗
• InjuryFeb 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 7 YEARS 8 MONTHS POST INITIAL OPERATION. THE PATIENT RETURNED TO THE SURGEONS OFFICE WITH COMPLAINTS OF PAIN, AND DISSATISFACTION WITH THEIR HIP. UPON EXAMINATION, THE PATIENT HAS A RECALLED POLYETHYLENE LINER. THE PATIENT UNDERWENT A POLY ACETABULAR LINER SWAP AND A FEMORAL HEAD SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 21446135 ↗
• InjuryJan 30, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE POLY WEARING OVER TIME. THE PATIENT WAS REVISED TO EXACTECH DEVICES, BUT THE ACETABULAR SIDE WAS REMOVED AND REPLACED WITH COMPETITOR DEVICES. 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: Insufficient Information

  MAUDE report 21280252 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain

  MAUDE report 20200614 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 66 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND DIFFICULTY WALKING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain

  MAUDE report 20146660 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 53 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Pain

  MAUDE report 20126689 ↗
• InjuryJul 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 75 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 19839242 ↗
• InjuryJul 15, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, A PATIENT HAD THEIR HIP REVISED. THE GXL LINER AND CERAMIC HEAD WHERE REPLACED WITH THE SAME IMPLANTS AND SIZES. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT CAUSE A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Insufficient Information; Pain

  MAUDE report 19741236 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 6 YEARS 11 MONTHS AFTER A RIGHT THA, THE PATIENT WAS REVISED DUE TO PAIN, AND DISSATISFACTION WITH THEIR HIP. UPON EXAMINATION, THE PATIENT HAS A RECALLED POLY LINER. THE POLY LINER AND FEMORAL HEAD WERE REVISED. THE PATIENT LEFT THE OR STABLE. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT CAUSE A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT RETURNING. THEY WERE SENT TO THE LAB AND LEGAL HOLD AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 19660983 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 59 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 19656554 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT HIP ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 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: Failure of Implant; Pain; Synovitis

  MAUDE report 19378217 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Distress; Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 19375596 ↗
• InjuryApr 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2018 AND THEN WAS REVISED ON (B)(6) 2024. PATIENT REQUIRED REVISION SURGERY FOR POLYETHYLENE PROSTHESIS WEAR. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS 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; Inflammation; Osteolysis; Pain; Synovitis

  MAUDE report 19186996 ↗
• InjuryApr 24, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE 71 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2018. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH A RECALLED HIP LINER AND WAS REVISED ON (B)(6) 2024 AND UNDERWENT AN ACETABULAR POLY LINER SWAP AND FEMORAL HEAD SWAP DUE TO OBVIOUS EARLY POLY WEAR ON X-RAY, PAIN AND DISSATISFACTION WITH THEIR HIP. 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; Pain

  MAUDE report 19177901 ↗
• InjuryApr 15, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, WHO HAD AN INITIAL TOTAL HIP REPLACEMENT ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH A RECALLED HIP LINER. THE PATIENT WAS SCHEDULED FOR A REVISION OF THEIR TOTAL HIP. THE PATIENT HAD REVISION SURGERY AND UNDERWENT AN ACETABULAR POLY LINER SWAP AND FEMORAL HEAD SWAP. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED PRODUCTS ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19111601 ↗
• InjuryMar 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT HIP IMPLANT ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS, 2 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: LEFT HIP REPLACEMENT POLYETHYLENE WEAR AND OSTEOLYSIS. THERE WAS EVIDENCE OF REACTION IN THE SOFT TISSUE CONSISTENT WITH RESPONSE TO OSTEOLYSIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 18858182 ↗
• InjuryFeb 7, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2016. THEY UNDERWENT RIGHT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 7 YEARS 2 MONTHS POST PRIMARY PROCEDURE. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF DEVICE, THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS ATTACHED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 18657675 ↗
• InjuryDec 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL THA, THE MALE PATIENT WAS REVISED DUE TO PAIN. POLY WEAR WAS NOTED BY SURGEON. A NEW VIT E LINER AND CERAMIC HEAD WERE IMPLANTED. THERE WAS NO ISSUES WITH SURGERY. PHOTOS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18395188 ↗
• InjuryNov 10, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT THA, THIS 55 Y/O MALE PATIENT WAS REVISED. THE PATIENT PRESENTED TO SURGEONS OFFICE WITH COMPLAINTS OF THEIR TOTAL HIP. THE POLYETHYLENE HIP LINER IMPLANT WAS A GXL RECALLED LINER SHOWING WEAR ON IMAGING. THE PATIENT WAS SCHEDULED FOR A HIP REVISION POSSIBLE HEAD AND LINER EXCHANGE. DURING THE REVISION SURGERY, THE FEMORAL HEAD WAS REMOVED AND THE GXL RECALLED LINER WAS REMOVED. A NEW VITAMIN E XLE HIP LINER WAS IMPLANTED ALONG WITH A NEW FEMORAL HEAD IMPLANT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING - THE IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

  Patient problems: Discomfort; Failure of Implant; Insufficient Information; Muscle Weakness/Atrophy; Pain; Synovitis

  MAUDE report 18110372 ↗
• InjuryNov 7, 2023Naturally Worn; Insufficient Device Problem Information; Lack of Effect; Naturally Worn; Insufficient Device Problem Information; Lack of Effect

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP INITIAL RIGHT THA, THIS 75 Y/O MALE PATIENT WAS REVISED. THE PATIENT PRESENTED BACK TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN AND STIFFNESS IN THEIR THA. UPON EXAMINATION AND IMPLANT RESEARCH THE PATIENT HAS A RECALLED POLY IMPLANT AND EARLY WEAR WITH CONCERNS OF OSTEOLYSIS. THE PATIENT WAS SCHEDULED FOR A REVISION THA POSSIBLE POLY SWAP. THE PATIENT OBTAINED AN ACETABULAR POLY LINER SWAP AND A FEMORAL HEAD SWAP WITH JOINT DEBRIDEMENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING - THE IMPLANTS ARE SENT TO THE HOSPITAL LAB AND THEN LEGAL.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 18083304 ↗
• InjuryOct 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 3 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: LEFT HIP REPLACEMENT POLYETHYLENE WEAR AND OSTEOLYSIS. THE HEAD WAS DISLOCATED AND THE HEAD REMOVED. THERE WAS NOT RUNIONOSIS. THERE WAS EVIDENCE OF REACTION IN THE SOFT TISSUE CONSISTENT WITH RESPONSE TO OSTEOLYSIS. THE CUP WAS WELL FIXED. THE LINER WAS REMOVED. THIS HAD OBVIOUS CHANGES CONSISTENT WITH POLYETHYLENE WEAR. THE PATIENT WAS TAKEN TO THE RECOVERY IN A STABLE CONDITION.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 18030429 ↗
• InjuryOct 18, 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'S LINER AND HEAD WERE REVISED ON (B)(6) 2023 DUE TO THE RECALL. 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: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 17959969 ↗
• InjurySep 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: MECHANICAL FAILURE, POLYETHYLENE WEAR LEFT HIP. FINDINGS: GROSS POLYETHYLENE WEAR AND SYNOVITIS. PATIENT WAS EXTUBATED TAKEN THE PACU IN STABLE CONDITION. NO COMPLICATIONS.

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

  MAUDE report 17817323 ↗

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-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-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-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-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-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,