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Novation 132-40-53Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

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

Adverse event reports
19
Deaths reported
0
Injuries reported
19
Recalls naming it
2

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885862207043), received between Aug 5, 2022 and Mar 19, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 3 reportsJun 2024: 2 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 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: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 11, 2022Open, 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 · FDA record ↗

  2. Jun 29, 2021Open, 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-2123-2021 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Device problems

  • Naturally Worn19
  • Adverse Event Without Identified Device or Use Problem3
  • Fracture2
  • Insufficient Device Problem Information2
  • Crack1

Patient problems

  • Failure of Implant11
  • Pain9
  • Insufficient Information8
  • Osteolysis7
  • Ambulation or Postural Difficulties1
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Discomfort1
  • Joint Impingement1

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 19, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 5 YEARS 2 MONTH POST INITIAL OPERATION. THE PATIENT RETURNED TO THE SURGEONS OFFICE WITH COMPLAINTS OF PAIN AND DISSATISFACTIONS WITH THEIR HIP. UPON EXAMINATION THE PATIENT HAS ACETABULAR POLYETHYLENE WEAR AND HAD A RECALLED IMPLANT. THE PATIENT UNDERWENT A FULL ACETABULAR CUP REVISION TO A COMPETITORS DEVICE. THE FEMORAL STEM WAS STABLE DESPITE OSTEOLYSIS SHOWN AROUND THE STEM ON X-RAY AND A NEW FEMORAL HEAD AND ADAPTOR SLEEVE WAS USED. DUE TO POLYETHYLENE WEAR AND OSTEOLYSIS BEHIND THE ACETABULAR CUP THE PATIENT HAD TO UNDERGO A FULL ACETABULAR CUP REVISION REQUIRING BONE GRAFT SUBSTITUTE. TWO FEMORAL HEAD ALLOGRAFT'S WERE USED TO FILL IN THE ACETABULAR OSTEOLYSIS HOLES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Discomfort; Osteolysis; Pain

    MAUDE report 21643079 ↗
  • InjurySep 16, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS 59 Y/O MALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 5 YEARS POST OP. THE PATIENT RETURNED TO SURGEONS OFFICE COMPLAINING OF PAIN, SWELLING, AND DISSATISFACTION WITH THEIR LEFT PRIMARY TOTAL HIP. THE POLY AND A RECALLED IMPLANT WERE IN QUESTION AND SHOWN TO BE WORN ON X-RAY. THE PATIENT UNDERWENT AN ACETABULAR POLY IMPLANT AND A FEMORAL HEAD SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: IMPLANTS ARE SENT TO THE LAB AND LEGAL.

    Patient problems: Pain; Swelling/ Edema

    MAUDE report 20233425 ↗
  • InjurySep 12, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 51 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain

    MAUDE report 20200328 ↗
  • InjuryJul 16, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 40 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; Pain

    MAUDE report 19751400 ↗
  • InjuryJun 11, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 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 19508962 ↗
  • InjuryJun 10, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 115 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 19505102 ↗
  • InjuryMay 17, 2024Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 7 YEARS AND 5 MONTHS POST THE INITIAL THA, THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF THEIR LEFT HIP. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAD A RECALLED HIP LINER AND IT WAS SHOWN ON THE X-RAY TO HAVE WEAR AND FEMORAL HEAD MIGRATION WITHIN THE ACETABULAR IMPLANT. THE PATIENT WAS SCHEDULED FOR LEFT HIP REVISION POSSIBLE POLY LINER AND FEMORAL HEAD SWAP VS. FULL REVISION. THE PATIENT UNDERWENT LEFT HIP REVISION ON (B)(6) 2024. DURING THE REVISION, THE PATIENT PRESENTED WITH EXCESSIVE HIP POLY LINER WEAR, AND THE POLY LINER WAS FRACTURED. THE FEMORAL HEAD WAS CONTACTING THE METAL CUP AND CREATED METALLOSIS WITHIN THE HIP JOINT CAPSULE. THERE WAS OSTEOLYSIS BEHIND THE ACETABULAR CUP AND THE IMPLANTED PRESENTED TO BE LOOSE. THE ACETABULAR CUP WAS REMOVED, THE HIP JOINT WAS DEBRIDED FROM METALLOSIS TISSUE AND BONE, AND THE PATIENT REQUIRED AN ALLOGRAFT FEMORAL HEAD BONE GRAFTING SUBSTITUTE WITHIN THE ACETABULUM. A NEW ZB G7 MULTI-HOLE CUP WAS IMPLANTED WITH SCREWS AND A LATERALIZED HIP LINER. A 36MM +10 MM HEAD WAS IMPLANTED TO MATCH THE ZB COMPONENTS. THE SURGEON HAD TO MAKE UP LEG LENGTH WITH +10

    Patient problems: Failure of Implant

    MAUDE report 19341847 ↗
  • InjuryMay 15, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

    AS REPORTED, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL THA, THE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS AND POLY WEAR. THE POLY WAS IN SEVERAL PIECES. NO ISSUES WITH SURGERY.

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 19318904 ↗
  • InjuryMay 13, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THIS 76 Y/O FEMALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 6 YEARS 2 MONTHS POST OP. THE PATIENT HAD AN ORIGINAL EXACTECH THA ON (B)(6) 2018. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN, AND DISSATISFACTION WITH THEIR HIP. UPON EXAMINATION, THE PATIENT HAS A RECALLED POLY LINER. THE PATIENT WAS SCHEDULED FOR A REVISION TOTAL HIP REPLACEMENT POSSIBLE POLY LINER AND FEMORAL HEAD SWAP. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024 AND UNDERWENT A POLY ACETABULAR LINER SWAP AND FEMORAL HEAD SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, SENT TO LAB AND LEGAL HOLD AT THE HOSPITAL.

    Patient problems: Failure of Implant; Pain

    MAUDE report 19296400 ↗
  • InjuryMar 6, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A 72 YO MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PREMATURE WEAR OF THEIR GXL LINER. THE SURGEON DID A HEAD AND LINER EXCHANGE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT. NO X-RAYS OR DEVICE IMAGES WERE AVAILABLE. THE EXPLANTED DEVICES ARE NOT ABLE TO BE RETURNED. THEY WERE SENT TO LEGAL. NO FURTHER INFORMATION.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 18850283 ↗
  • InjuryFeb 29, 2024Crack; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Crack; Naturally Worn; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON WITH A RECALLED HIP LINER AND WAS SCHEDULED FOR A REVISION. THE ACETABULAR POLY LINER AND THE FEMORAL HEAD WERE REPLACED TO A BIOLOX DELTA ADAPTER 16/18-12/14; +3.5MM SN: (B)(6), BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD SN: (B)(6), AND A NV EHXL LIPPED LNR G3 40MM SN: (B)(6). THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE SENT TO THE HOSPITAL¿S LAB AND LEGAL DEPT. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Patient problems: Insufficient Information

    MAUDE report 18813258 ↗
  • InjuryAug 9, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    REVISION OPERATIVE REPORT ON (B)(6) 2023-PRE-OPERATIVE LONG DIAGNOSIS: FAILED LEFT TOTAL HIP REPLACEMENT SECONDARY TO POLY WEAR. EVIDENCE OF OSTEOLYSIS AND POLY WEAR INVOLVING MAINLY THE ACETABULUM. THE POLY WAS NOTED TO BE WEARING EXCESSIVELY. THERE WAS NOTED OSTIAL LYSIS BEHIND THE SCREW HOLES AS WELL AS OSTEOLYSIS OVER THE SUPERIOR RIM OF THE ACETABULAR COMPONENT. FEMORAL HEAD REMOVED; THERE WAS SLIGHT TRUNNION METALLOSIS. BONE SCAN NEGATIVE FOR LOOSENING. REVISION LEFT THA OF ACETABULAR COMPONENT ONLY. THE PATIENT TOLERATED THE PROCEDURE WELL. NO OTHER INFORMATION IS PROVIDED.

    Patient problems: Failure of Implant; Insufficient Information; Metal Related Pathology; Osteolysis

    MAUDE report 17490561 ↗
  • InjuryJul 25, 2023Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT THA, THIS 72 Y/O MALE PATIENT WAS REVISED. THE PATIENT RETURNED TO SURGEONS OFFICE COMPLAINING ABOUT THEIR PRIMARY HIP. PAIN AND DISSATISFACTION. UPON EXAMINATION AND IMAGING THE POLY SHOWED WEAR AND IS INVOLVED IN THE RECALL. THE PATIENT UNDERWENT REVISION RIGHT THA ON (B)(6) 2023 WHERE THE HEAD AND POLY LINER WERE SWAPPED. A NEW VITAMIN E LINER AND CERAMIC HEAD WERE IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. NO X-RAYS PROVIDED. PRODUCT NOT BEING RETURNED - THE IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL .

    Patient problems: Failure of Implant; Pain

    MAUDE report 17388069 ↗
  • InjuryJul 20, 2023Naturally Worn; Naturally Worn

    AS REPORTED, THE PATIENT HAD AN ORIGINAL EXACTECH PRIMARY TOTAL HIP REPLACEMENT ON (B)(6) 2017. THE 77 Y/O FEMALE PATIENT RETURNED TO SURGEON'S OFFICE COMPLAINING ABOUT THEIR PRIMARY HIP PAIN AND DISSATISFACTION. UPON EXAMINATION AND IMAGING THE POLY SHOWED WEAR AND IS INVOLVED IN THE RECALL. THE PATIENT UNDERWENT REVISION LEFT THA ON (B)(6) 2023 WHERE THE PATIENT UNDERWENT A FULL TOTAL HIP REVISION USING COMPETITOR'S DEVICES. THE PATIENT LEFT THE OPERATING ROOM (OR) STABLE. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 30-45 MINUTES SURGERY DELAY DUE TO PATIENT HAD TO BE UNDER ANESTHESIA AND IN SURGERY LONGER THAN ANTICIPATED WHEN GOING TO A FULL REVISION. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

    Patient problems: Failure of Implant; Pain

    MAUDE report 17362036 ↗
  • InjuryJul 20, 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), 2017. THEY UNDERWENT LEFT HIP REVISION SURGERY ON (B)(6), 2022, APPROXIMATELY 5 YEARS 1 MONTH POST PRIMARY IMPLANTATION. 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: Failure of Implant; Insufficient Information; Osteolysis

    MAUDE report 17360859 ↗
  • InjuryJul 6, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT THA, THE 71 Y/O MALE PATIENT PRESENTED WITH COMPLAINTS OF PAIN AND DISSATISFACTION WITH THEIR PRIMARY EXACTECH HIP. THE PATIENT HAD A RECALL GXL POLY LINER AND WAS BOOKED FOR REVISION SURGERY. THE PATIENT UNDERWENT TOTAL ACETABULAR REVISION TO A EXACTECH 28MM COCR +10MM HEAD AND COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 30-45 MINS SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE PRODUCTS WERE SENT TO THE LAB AT THE HOSPITAL.

    Patient problems: Osteolysis; Pain

    MAUDE report 17274412 ↗
  • InjuryApr 6, 2023Naturally Worn; Naturally Worn

    AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2017 . THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO PREMATURE POLY WEAR AND POLY RECALL. THE POLY AND FEMORAL HEAD WERE EXCHANGED. THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WERE WELL-FIXED FEMORAL AND ACETABULAR COMPONENTS. THERE WAS A MODERATE AMOUNT OF VISIBLE POLYETHYLENE WEAR WITHIN THE ACETABULUM FROM THE POLYETHYLENE. THERE WAS ALSO A MODERATE AMOUNT OF OSTEOLYSIS SUPERIOR TO THE ACETABULUM, AS VISUALIZED THROUGH THE SCREW HOLES. PUTTY WAS USED TO FILL THIS BACK SIDE VOID. A LATERALIZED LINER WAS UTILIZED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 16697410 ↗
  • InjurySep 27, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

    THE 76 Y/O MALE PATIENT PRESENTED TO THE SURGEON'S OFFICE COMPLAINING OF RIGHT HIP SQUEAKING. THE PATIENT UNDERWENT A POSTERIOR PRIMARY THA ORIGINALLY ON (B)(6) 2017. RECENT X-RAYS WERE TAKEN IN LATE (B)(6) 2022. X-RAYS SHOWED SIGNIFICANT POLYETHYLENE WEAR, OSTEOLYSIS, AND OSTEOPHYTES AROUND THE CUP. THE PATIENT'S ORIGINAL IMPLANTS ARE: 8MM ALTEON HA STANDARD NO COLLAR STEM, 56MM INTEGRIP CLUSTER CUP 56MM, G3, ALTEON 6.5MM SCREWS 30MM, 40MM, NOVATION GXL LINER LIPPED 40MM, G3, AND A BIOLOX DELTA FEMORAL HEAD 40MM +3.5MM. THE ORIGINAL APPROACH WAS POSTERIOR. THE NOVATION GXL LINER SERIAL NUMBER WAS RUN THROUGH THE RECALL SEARCH AND DID COME BACK AS A POLY THAT IS AFFECTED IN THE CURRENT EXACTECH POLY RECALL. RECALL INFORMATION WAS GIVEN TO THE SURGEON'S OFFICE AND TO THE PATIENT. THE PATIENT WAS SCHEDULED FOR A REVISION THA POSSIBLE HEADLINER SWAP FOR THE IMPLANTS IN QUESTION FOR THE REASONS STATED ABOVE. REVISION THA SURGERY WAS SCHEDULED FOR (B)(6) 2022. POSTERIOR APPROACH WAS USED FOR THE REVISION SURGERY. THE SURGEON DISSECTED DOWN TO THE IMPLANTS AND SAW POLY DEBRIS AND METALLOSIS AROUND THE IMPLANTS AND TISSUES. THE FEMORAL HEAD WAS REMOVED USING A TAMP. THE ACETABULUM WAS EXP

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 15494165 ↗
  • InjuryAug 5, 2022Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL POST LEFT THA, THIS 71 Y/O MALE PATIENT WAS IN SOME PAIN AND GXL LINER WAS HAVING PROBLEMS. SURGEON REVISED THE GXL LINER AND BIOLOX HEAD. SURGEON RE-IMPLANT A XLE LINER LIPPED 40MM AND BIOLOX DELTA ADAPTER 3.5 WITH 40MM HEAD. THERE WAS NO BREAKAGE OF A DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS WERE RECEIVED. THE DEVICE WILL NE RETURN.

    Patient problems: Failure of Implant; Joint Impingement; Pain

    MAUDE report 15178820 ↗

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-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
  • 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-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-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,

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.