Novation 132-28-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885862023155), received between Dec 22, 2021 and Sep 8, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Naturally Worn” (14 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-2121-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Naturally Worn

  Approximately 8 years after implantation of a left total hip prosthesis, the patient developed groin discomfort that progressed to pain. Radiographic imaging and bone scan findings did not indicate loosening of the prosthetic components. However, a large granulomatous lesion was identified in the region of implant wear and was associated with suspected polyethylene wear.The patient underwent revision surgery. During the procedure, the granuloma was excised, and the bearing surface components were replaced. The metal implant components were reported to be well-fixed and well-integrated with the surrounding bone. Areas of osteolysis were reconstructed using allograft bone graft material. No further information is available.

  Patient problems: Granuloma; Osteolysis; Pain

  MAUDE report 50670175 ↗
• InjuryNov 7, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON AN UNKNOWN DATE. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR RIGHT THA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION THE PATIENT WAS SCHEDULED TO HAVE A REVISION THA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT WAS REVISED. THE PATIENT REQUIRED DBM BONE GRAFT TO BE PACKED BEHIND THE ACETABULAR CUP DUE TO OSTEOLYSIS CAUSING A BONE VOID BEHIND THE IMPLANT. THE ACETABULAR CUP AND FEMORAL STEM WERE STABLE. THE PATIENT UNDERWENT AN ACETABULAR LINER SWAP AND FEMORAL HEAD SWAP. 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: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 23496755 ↗
• InjuryAug 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP TOTAL ARTHROPLASTY. SUBSEQUENTLY, THIRTEEN AND HALF (13.5) YEARS LATER, THE PATIENT'S X-RAYS INDICATED A MALPOSITIONED ACETABULAR CUP AND POLYETHYLENE WEAR. THE PATIENT UNDERWENT A LEFT HIP REVISION FOUR (4) DAYS LATER. THE ACETABULAR CUP, LINER AND FEMORAL HEAD WERE REVISED. THE CUP AND LINER WERE NOTED TO BE A COMPETITOR'S IMPLANTS. INTRAOPERATIVELY, IT WAS NOTED THE PATIENT NEEDED BONE GRAFT DUE TO POLY WEAR, OSTEOLYSIS AND CUP REMOVAL. THERE WAS AN UNEXPECTED SURGICAL DELAY OF 30-45 MINUTES REPORTED DUE TO THE ACETABULAR CUP BEING LOOSE AND FALLING OUT. AS A RESULT, A FULL ACETABULAR COMPONENT REVISION WAS NEEDED INSTEAD OF THE PLANNED REVISION OF JUST THE POLYETHYLENE COMPONENTS AND THE FEMORAL HEAD EXCHANGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22859554 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 154 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: Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19646490 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 12 YEARS 7 MONTHS AFTER RIGHT PRIMARY TOTAL HIP REPLACEMENT, THE PATIENT RETURNED COMPLAINING OF PAIN AND DISSATISFACTION WITH THEIR LEFT PRIMARY HIP. THE POLY AND A RECALLED IMPLANT WERE WORN UPON EXAMINATION AND IMAGING. THE PATIENT UNDERWENT REVISION LEFT THA WHERE THE STEM, HEAD, AND LINER WERE REMOVED. A NEW LINER WAS IMPLANTED INTO THE CUP AND A COMPETITORS STEM AND THE HEAD WERE IMPLANTED INTO THE FEMORAL SIDE. THIS EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL PROLONGATION/DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 19611468 ↗
• InjuryMar 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 12 YEARS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. 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 18958320 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT IS REQUIRING A HIP REVISION SURGERY. A SPECIAL APPROVAL FOR IMPORT OF A DEVICE WAS REQUESTED. NO FURTHER DETAILS KNOWN AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18946225 ↗
• InjuryNov 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2009. APPROXIMATELY 13 YEARS AND 8 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 TOTAL HIP OSTEOLYSIS, POLYWEAR. THE ACETABULAR LINER WAS FOUND TO BE WORN WITH EVIDENCE OF DELAMINATION. THE ACETABULAR COMPONENT WAS FOUND TO BE WELL-FIXED WITH SURROUNDING OSTEOLYSIS, ESPECIALLY POSTERIORLY. THE PATIENT WAS TRANSFERRED TO THE BED AND THEN RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 18226581 ↗
• InjuryJun 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6)2015. APPROXIMATELY 7 YEARS AND 11 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 (B)(6) 2023. POST-OP DIAGNOSIS: 1. FAILED LEFT HIP TOTAL HIP REPLACEMENT ARTHROPLASTY. 2. MORBID OBESITY. THE SURGEON DISLOCATED THE HIP ANTERIORLY CLEARED SOFT TISSUE AROUND THE STEM AND COULD SEE SOME MILD OSTEOLYSIS THAT WAS DEBRIDED AND DID NOT REQUIRE BONE GRAFTING. THE STEM WAS WELL FIXED. THE SURGEON REMOVED THE HEAD AND THE TRUNNION WAS IN GOOD CONDITION. I TUCKED THE TRUNNION ALONG THE POSTERIOR SUPERIOR ACETABULUM AND EXPOSED THE RIM OF THE ACETABULUM. THERE WAS SEVERE POLYETHYLENE WEAR THAT BEGINNING TO FLAKE SOME POSTERIORLY, SUPERIORLY. A STERILE BANDAGE WAS APPLIED.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17218105 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, HAD A HIP ARTHROPLASTY ON (B)(6) 2011 THEN THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019, APPROXIMATELY 8 YEARS POST IMPLANT. THE LEGAL DOCUMENTATION PROVIDED IS NOT SPECIFIC TO THE LIMB AFFECTED BY THE DEVICE TYPES. 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: Insufficient Information

  MAUDE report 17208628 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, HAD A HIP ARTHROPLASTY ON (B)(6) 2009 THEN THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014, APPROXIMATELY 5 YEARS POST IMPLANT. THE LEGAL DOCUMENTATION PROVIDED IS NOT SPECIFIC TO THE LIMB AFFECTED BY THE DEVICE TYPES. 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: Insufficient Information

  MAUDE report 17208227 ↗
• InjuryJun 12, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2012. NOT YET EXPLANTED. THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT. 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; Insufficient Information

  MAUDE report 17106366 ↗
• InjuryMay 31, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT HIP REPLACEMENT ON (B)(6) 2011 DUE OSTEOARTHRITIS. THEY HAD REVISION SURGERY (B)(6) 2022, APPROXIMATELY 11 YEARS AFTER THEIR INITIAL IMPLANTATION. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH IMPENDING WEAR THROUGH OF POLYETHYLENE LINER. THE SURGEON NOTED "THE PSEUDOCAPSULE AND PIRIFORMIS WERE DAMAGED, LIKELY FROM THE PREVIOUS APPROACH. THERE IS FLUID TENTING THE CAPSULE, WHICH IS CAUSING THIS TO BE PATULOUS", AND "ON ENTERING JOINT, WE SEE A LARGE AMOUNT OF WEAR RELATED SYNOVITIS, CLEAR SYNOVIAL FLUID AND SOME METAL STAINING, BUT PREOPERATIVE FLUID TESTING WAS NEGATIVE FOR INFECTION." THE FEMORAL COMPONENT WAS PROVOCATIVELY TESTED AND FOUND TO BE WELL FIXED. THERE WAS A MASSIVE OSTEOLYSIS EXTENDING IN ALL PLANES INCLUDING THE ISCHIUM, ILIUM, AND MEDIALLY. THE PATIENT TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION AFTER REVERSAL FROM ANESTHESIA. 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; Insufficient Information

  MAUDE report 17033155 ↗
• InjuryApr 25, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A 58 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON HAD INDICATED THAT THE PATIENT WAS LESS THAN 3 YEARS OUT AND WAS COMPLETELY WORN. THE PATIENT HAD DEVELOPED WEARING OF THE ARTICULAR BEARING SURFACE. PREOP/POST OP DIAGNOSIS: RIGHT HIP REPLACEMENT PROSTHESIS WEAR AND OSTEOLYSIS. RIGHT HIP REPLACEMENT, REVISION OF FEMORAL HEAD AND ACETABULAR LINER, AND DEBRIDEMENT OF OSTEOLYTIC DEFECTS IN ACETABULAR BONE WITH ALLOGRAFT BONE GRAFTING PROCEDURE INDICATED. INFORMED CONSENT WAS OBTAINED. INCISION WAS MADE. FLUID WAS ASPIRATED FROM THE HIP JOINT AND WAS SENT FOR ANALYSIS. THE FLUID WAS CLOUDY WITHOUT FRANK PURULENCE. RESULTS ULTIMATELY DEMONSTRATED PARTICULATE FOREIGN DEBRIS. CELL COUNT WAS TOO LOW TO PERFORM CELL COUNT ANALYSIS. THERE WAS EXPANSION OF THE SYNOVIUM WITHIN THE HIP JOINT. SECTIONS WERE TAKEN OF THE SYNOVIUM AND CAPSULE. THE FINDINGS WERE NOT CONSISTENT WITH ACUTE INFLAMMATION. GROSSLY, THE APPEARANCE OF THE SYNOVIUM AND CAPSULE WERE DEMONSTRATING 10 TYPE VILLOUS HYPERTROPHY CONSISTENT WITH DEPOS

  Patient problems: Osteolysis

  MAUDE report 16809090 ↗
• InjuryDec 22, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2014 WITH NOVATION GUP 1 METALLIC HEAD PROSTHESIS AND IN THE REVIEW IN (B)(6) 2021 SHE PRESENTS GREAT WEAR OF POLYETHYLENE WITH A LARGE SUPRA-ACETABULAR CYST.

  Patient problems: Failure of Implant

  MAUDE report 13061040 ↗

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