Novation 136-36-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10885862024329), received between Dec 20, 2019 and Feb 25, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Naturally Worn” (33 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.

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-2128-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS AND 9 MONTHS POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED A GRINDING SENSATION IN THEIR HIP AND WAS REVISED DUE TO BEING UNSTABLE AND DISLOCATING POSTERIORLY. AN IMAGE PROVIDED SHOWS WEAR OF THE LINER. 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: Crepitus; Joint Dislocation; Joint Laxity

  MAUDE report 24442043 ↗
• InjuryOct 15, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED WEAR OF THE ACETABULAR LINER AND HIP PAIN. AS A RESULT, THE PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SIX YEARS AND NINE MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23286649 ↗
• InjuryNov 27, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 MONTHS POST INITIAL LEFT TOTAL HIP ARTHROPLASTY (THA), THE PATIENT UNDERWENT REVISION AS THE POLY WAS WORN AND NEEDED REPLACING. DURING THE REVISION, IT WAS DETERMINED THAT THE CUP ALSO NEEDED TO BE REMOVED DUE TO BONE VOID. THE PATIENT WAS REVISED TO COMPETITOR ACETABULAR COMPONENTS AND THE SURGEON IMPLANTED THE EXACTECH BIOLOX DELTA OPTION 28MM HEAD AND +0 ADAPTER BECAUSE THE STEM STAYED INTACT. THE EVENT WAS NOT RELATED 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: Osteolysis

  MAUDE report 20792110 ↗
• InjuryOct 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED A 73 YO PATIENT, INITIAL RIGHT HIP IMPLANTED IN (B)(6) 2010, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 13 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. POLY WEAR OVER TIME REPORTED. THE PATIENT WAS REVISED TO A 146-36-52 NV EXHL LAT LNR G2 36MM. 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 PRODUCT WILL NOT BE RETURNED FOR ANALYSIS DUE TO HOSPITAL POLICIES. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20537396 ↗
• InjurySep 4, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS 67 Y/O FEMALE PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 14 YEARS 3 MONTHS POST OP. LINER WORE OUT. FEMORAL HEAD WAS EXCHANGED FOR AN EXACTECH BIOLOX OPTION 36MM HEAD W/ +3.5MM ADAPTER BUT A COMPETITORS LINER WAS IMPLANTED AND CEMENTED TO OUR CUP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: HOSPITAL POLICY.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 20140503 ↗
• InjuryAug 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT HAD A HIP PROSTHESIS CUP IMPLANTED BY EXACTECH. HE PRESENTED TO SURGEON WITH SWELLING IN HIS KNEE. AS A SECONDARY FINDING, A CHECK OF THE IMPLANTED HIP PROSTHESIS WAS CARRIED OUT. THE PATIENT WAS FREE OF SYMPTOMS IN THIS REGARD. THE X-RAY AND CT CHECK SHOWED AN INLAY THAT WAS ALMOST COMPLETELY WORN OUT CRANIALLY WITH A CLEAR DECENTRATION OF THE PROSTHESIS HEAD IN THE CUP AND CLEAR OSTEOLYSIS IN THE ACETABULUM, SO THAT THE INDICATION FOR PROSTHESIS REVISION WAS MADE. NEW CARDIAC ARRHYTHMIAS OCCURRED DURING THE INDUCTION OF SURGERY/ANESTHESIA, SO THE OPERATION WAS NOT CARRIED OUT. AFTER CARDIOLOGICAL CLARIFICATION, THE NEW OPERATION IS SCHEDULED FOR (B)(6) 2024.

  Patient problems: Arrhythmia; Osteolysis; Swelling/ Edema

  MAUDE report 20077065 ↗
• InjuryAug 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 116 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS OSTEOLYSIS, METALLOSIS, POLY WEAR, AND FEMORAL LOOSENING. 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

  MAUDE report 20068865 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 116 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS OSTEOLYSIS, METALLOSIS, POLY WEAR, AND FEMORAL LOOSENING. 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

  MAUDE report 20067919 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED DUE TO WEAR. THE CUP WAS REMOVED AND A COMPETITOR'S DEVICE WAS IMPLANTED. AN EXACTECH HEAD WAS USED. 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 20044534 ↗
• InjuryJul 10, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LEFT HIP PAIN, SNAPPING, SCARRING, AND IRRITATION; EVIDENCE OF POLYETHYLENE IRRITATION; CRACKING AND ECCENTRIC WEAR OF POLYETHYLENE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. 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; Failure of Implant; Implant Pain; Scar Tissue; Synovitis

  MAUDE report 19709416 ↗
• InjuryJun 25, 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 7 YEARS LATER THE PATIENT WAS REVISED. 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: Insufficient Information

  MAUDE report 19608872 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYSIS, AND HETEROTOPIC BONE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Osteolysis

  MAUDE report 19484457 ↗
• InjuryJun 6, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LIMITED ROM, LOSS OF MOBILITY, ANXIETY, EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Anxiety; Emotional Changes; Implant Pain; Loss of Range of Motion; Osteolysis

  MAUDE report 19479696 ↗
• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 195 MONTHS AFTER A 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 19453552 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 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 19329404 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19326162 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 89 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: Failure of Implant; Insufficient Information

  MAUDE report 19326143 ↗
• InjuryMay 8, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016 AND A SURGICAL REVISION ON (B)(6) 2024; APPROXIMATELY 7 YEARS 9 MONTHS AFTER IMPLANT. OPERATIVE REPORT OF (B)(6) 2024- PROCEDURE: REVISION LEFT TOTAL HIP REPLACEMENT/ REVISED TO EXACTECH DEVICES. THE FEMORAL COMPONENT WAS FOUND TO BE STABLE AND WELL POSITIONED. THE LINER IS REMOVED. THE CUP IS FOUND TO BE STABLE. THE OSTEOLYTIC LESIONS ARE DEBRIDED, THEN PACKED WITH CANCELLOUS CHIPS. THE PATIENT TOLERATED THE PROCEDURE WELL, WITHOUT COMPLICATION AND TRANSFERRED TO THE RECOVERY ROOM IN A STABLE POST- OPERATIVE CONDITION. (PREOPERATIVE DIAGNOSIS IS NOT PROVIDED) NO DEVICE RETURN. THERE IS NO ADDITIONAL INFORMATION PROVIDED/AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 19267140 ↗
• InjuryApr 18, 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 A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19132221 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19132201 ↗
• InjuryFeb 6, 2024Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED HIMSELF FOR A CHECK-UP OF THE DEVICE IMPLANTED IN 2013 LEFT HIP PROSTHESIS. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD A VERY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THERE IS AN ADDITIONAL FINDING PRONOUNCED LUMBAR SPINE SYNDROME IN POLYMYALGIA RHEUMATICA. DURING THE REVISION SURGERY ON (B)(6) 2023, HE WAS ABLE TO RADIOLOGICAL FINDINGS ARE CONFIRMED. BECAUSE THE SOCKET WAS LOOSE AND OSTEOLYSIS OCCURRED DUE TO THE SIZE THEN THE COMPLETE SOCKET CHANGE TO A REVISION HIP CUP WITH TAB AND ILIAC PIN. AS PART OF THE REPLACEMENT OPERATION, THE CHANGING THE PROSTHETIC HEAD.

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

  MAUDE report 18650814 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 10 YEARS 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 (B)(6) 2023. DIAGNOSIS: FAILED RIGHT THA (ADVANCED WEAR OF POLYETHYLENE LINER WITH SIGNIFICANT PERIACETABULAR OSTEOLYSIS). ENCOUNTERED EXTENSIVE REACTIVE GRANULOMATOUS SYNOVIAL TISSUE. FEMORAL HEAD WAS REMOVED WITH TAMP AND A MALLET. BONE IMPLANT INTERFACE OF THE FEMUR STEM WAS CLEARED¿FOUND TO BE WELL FIXED AND REASONABLY POSITIONED. STEM NOT REVISED. POLYETHYLENE LINER WAS REMOVED. AN EXTENSIVE SYNOVECTOMY WAS PERFORMED TO REMOVE GRANULOMATOUS TISSUES. REMOVED THE ACETABULUM WITH MINIMAL BONE LOSS. AS EXPECTED FROM PREOP XR AND CT THERE WAS EXTENSIVE OSTEOLYSIS OF THE ILIUM, AND LESS SO OF THE PUBIS AND ISCHIUM. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS AND THE PROCEDURE WENT AS PLANNED.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 18083689 ↗
• InjurySep 20, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT HIP WAS REVISED. SURGEON REPLACED LINER WITH NEUTRAL XLE CUP AND A +3.5 36MM BIOLOX DELTA OPTIONS HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION /MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - HOSPITAL KEPT LINER.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17780273 ↗
• InjurySep 1, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 2 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 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; Joint effusion; Osteolysis; Pain; Scar Tissue

  MAUDE report 17672670 ↗
• InjuryJul 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT HIP REPLACEMENT SURGERY ON (B)(6) 2016. THEY SUBSEQUENTLY UNDERWENT LEFT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 6 YEARS 10 MONTHS AFTER THEIR PRIMARY PROCEDURE. (B)(6) 2023 OP REPORT STATES THAT THERE WAS SOME MILD OSTEOLYSIS AROUND THE RIM OF THE ACETABULUM, BUT THE STEM WAS WELL FIXED AND RETAINED. THE TRUNNION OF THE FEMORAL HEAD WAS NOTED TO BE IN GOOD CONDITION. THE ACETABULAR LINER HAD SIGNIFICANT WEAR, SOME CRACKING ALONG THE SUPERIOR RIM OF THE ACETABULUM. THE CUP WAS WELL FIXED AND IN GOOD POSITION. THE CENTRAL HOLE AND AROUND THE RIM DID NOT INDICATE SIGNIFICANT OSTEOLYTIC DEFECTS; BONE GRAFTING WAS NOT NEEDED. 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: Failure of Implant; Osteolysis

  MAUDE report 17275471 ↗

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-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-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-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-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-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-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-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-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-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-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
• 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