Novation 132-32-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885862023315), received between Jun 22, 2021 and May 14, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Naturally Worn” (30 reports).

2 FDA recall records name this device's identifier, 2 still open.

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-2133-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A LEFT HIP REPLACEMENT. THE PATIENT LATER RETURNED TO THE PHYSICIAN¿S OFFICE WITH COMPLAINTS OF PAIN, STIFFNESS, DECREASED RANGE OF MOTION, INSTABILITY, AND DISSATISFACTION RELATED TO THEIR LEFT TOTAL HIP ARTHROPLASTY (THA). EVALUATION REVEALED THE PRESENCE OF A RECALLED GXL LINER, A MALPOSITIONED ACETABULAR CUP, ASSOCIATED BONE LOSS, AND FEMORAL COMPONENT LOOSENING. ALSO, PHOTOGRAPHS PROVIDED SHOW WEAR ON THE LINER. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY. THE PROCEDURE INVOLVED EXPLANTATION OF ALL EXISTING HIP COMPONENTS. DUE TO THE EXTENT OF BONE LOSS, ADDITIONAL BONE GRAFT SUBSTITUTE WAS REQUIRED. A REVISION LOCKING ACETABULAR CUP WAS IMPLANTED WITH A NEW ACETABULAR LINER, AND THE FEMORAL COMPONENT WAS REVISED WITH PLACEMENT OF A MONOBLOCK REVISION STEM. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 25174659 ↗
• InjuryMar 30, 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 24729850 ↗
• InjurySep 16, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 101 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 20223137 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 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 20179854 ↗
• InjuryAug 28, 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, OSTEOLYSIS AND SYNOVITIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 20089936 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA (MASTER CASE 2022 CA 002670) CASE NO: (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 85 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20070125 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 169 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 20063295 ↗
• InjuryAug 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 111 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, GROSS LINER WEAR, 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.

  Patient problems: Osteolysis

  MAUDE report 20048359 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A BILATERAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2020 AND THEN HAD A BILATERAL REVISION SURGERY APPROXIMATELY 3 YEARS 8 MONTHS LATER ON (B)(6) 2023. PATIENT WAS RECOMMENDED ELECTIVE REVISION SURGERY DUE TO IMPLANT RECALL FOR PROSTHESIS WEAR. DURING THE REMOVAL OF THE ORIGINAL IMPLANTS, IT WAS FOUND THAT THE ACETABULAR LINERS HAD GROSSLY MILD WEAR. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION; NO COMPLICATIONS AND PROCEDURE WAS TOLERATED WELL. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE IS NO OTHER INFORMATION PROVIDED/AVAILABLE.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 19913604 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MILD OSTEOLYSIS, WEAR DEBRIS, INFLAMMATORY SYNOVIUM. 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: Osteolysis; Scar Tissue; Synovitis

  MAUDE report 19712986 ↗
• InjuryJun 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD THEIR LEFT HIP IMPLANTED IN 2010, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 14 YEARS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THE PATIENT HAD AN OLD HIP IN AND NEEDED A NEW LINER. THE LINER HAD SUPERIOR WEAR AND THE PATIENT HAD A NEW HEAD AND LINER IMPLANTED. THERE WERE SMALL PLASTIC PARTICLES FROM THE WEAR FOUND DURING THE PROCEDURE WHICH WERE REMOVED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE EXPLANTED LINER WAS A RECALL DEVICE. NO X-RAYS WERE ABLE TO BE OBTAINED. NO DEVICE IMAGES WERE PROVIDED. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL WOULD NOT RELEASE THEM.

  Patient problems: Insufficient Information

  MAUDE report 19640978 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MILD TRUNNION WEAR DEBRIS, GROSS WEAR OF POLYETHYLENE COMPONENT, DELAMINATION, PERIPROSTHETIC 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis

  MAUDE report 19606579 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 99 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

  MAUDE report 19367089 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 1 MONTH 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: Failure of Implant; Insufficient Information

  MAUDE report 19281950 ↗
• InjuryApr 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2009 AND THEN WAS REVISED ON (B)(6) 2022. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR, COMPONENT LOOSENING, DEVICE FAILURE, REVISION SURGERY, JOINT PAIN, JOINT SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE GIVING WAY, DIFFICULTY WALKING AND ANTALGIC GAIT. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS 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: Ambulation or Postural Difficulties; Anxiety; Distress; Failure of Implant; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19164451 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2020 AND THEN WAS REVISED APPROXIMATELY 3 YEARS 8 MONTHS LATER ON (B)(6) 2023. PATIENT WAS RECOMMENDED ELECTIVE REVISION SURGERY DUE TO IMPLANT RECALL FOR PROSTHESIS WEAR. DURING THE REMOVAL OF THE ORIGINAL IMPLANT, GROSS FINDINGS OF THE RIGHT HIP JOINT INCLUDED MODERATE WEARING OF THE ARTICULAR BEARING. THERE WAS MILD LYSIS OF THE BONE AROUND THE RIM OF THE ACETABULUM AROUND THE PROXIMAL ASPECT OF THE FEMUR AFTER DISSECTION OF ASSOCIATED SOFT TISSUE WITH A RONGEUR AND A CURETTE. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION; NO COMPLICATIONS AND PROCEDURE WAS TOLERATED WELL. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE IS NO OTHER INFORMATION PROVIDED/AVAILABLE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS 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

  MAUDE report 19154867 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2020 AND THEN WAS REVISED APPROXIMATELY 3 YEARS 8 MONTHS LATER ON (B)(6) 2023. PATIENT WAS RECOMMENDED ELECTIVE REVISION SURGERY DUE TO IMPLANT RECALL FOR PROSTHESIS WEAR. DURING THE REMOVAL OF THE ORIGINAL IMPLANT, IT WAS FOUND THAT THE ACETABULAR LINER HAD GROSSLY MILD WEAR. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION; NO COMPLICATIONS AND PROCEDURE WAS TOLERATED WELL. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE IS NO OTHER INFORMATION PROVIDED/AVAILABLE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS 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; Osteolysis

  MAUDE report 19154532 ↗
• InjuryMar 16, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 13 YEARS POST INITIAL LEFT THA, THE 62 Y/O MALE PATIENT HAD A REVISION DUE TO POLY RECALL. PATIENT HAD THE LINER REMOVED AS WELL AS COCR HEAD. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE THE IMPLANTS WERE KEPT BY THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18919049 ↗
• InjuryDec 14, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 84 Y/O FEMALE PATIENT HAD AN ORIGINAL EXACTECH RIGHT THA PERFORMED ON 04/26/2016. THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, INSTABILITY, AND DISSATISFACTION WITH THEIR RIGHT HIP REPLACEMENT. THE PATIENT PRESENTED BACK TO THE PROVIDER WITH A DISLOCATED PROSTHESIS. THE PATIENT HAD A RECALLED HIP POLY LINER. THE PATIENT WAS SCHEDULED FOR A HIP REVISION POSSIBLE FEMORAL HEAD AND ACETABULAR LINER SWAP ON (B)(6) 2023. THE PATIENT UNDERWENT AN ACETABULAR LINER AND FEMORAL HEAD SWAP. DURING THE FIRST LINER IMPLANTATION, THE LINER DID NOT LOCK IN THE POSITION THAT THE SURGEON WANTED IT TO BE IN. HE REMOVED THE LINER, AND A NEW IMPLANT WAS OPENED AND RE-IMPLANTED IN THE DESIRED POSITION. THERE ARE TWO LINERS SHOWN ON THE PICTURE AND THE DARKER COLORED LINER IN THE PICTURE IS THE NEW XLE VITAMIN E LINER THAT WAS TAKEN OUT DUE TO POSITION AND A NEW ONE WAS REPLACED. PATIENT WAS REVISED TO NOVATION XLE LIPPED LINER G2 36MM, BIOLOX OPTION HEAD 36MM, BIOLOX OPTION ADAPTER +0MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 18327531 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 3 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2022. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. 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: Insufficient Information

  MAUDE report 18317544 ↗
• InjuryNov 22, 2023Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AND 7 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, DIAGNOSIS: CENTRAL SUBLUXATION OF RIGHT HIP FINDINGS: EVIDENCE OF PREVIOUS SUBLUXATION EVENTS WITH WEAR AND FRACTURING OF POSTERIOR POLYETHYLENE LINER. NO EVIDENCE OF PURULENCE OR SIGNS OF INFECTION. THE PATIENT WAS TRANSFERRED TO THE BED AND THEN RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 18190462 ↗
• InjuryOct 19, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2013. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO A FAILED CUP AND LINER - RECALLED POLY. 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: Aseptic loosening; Failure of Implant

  MAUDE report 17965047 ↗
• InjuryJun 12, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  ADDITIONAL INFORMATION VIA LEGAL-PATIENT REVISED TO EXACTECH DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2023-PRELIMINARY DIAGNOSIS- SEVERE POLYETHYLENE WEAR OF THE RIGHT HIP. RIGHT REVISION TOTAL HIP REPLACEMENT OF BOTH COMPONENTS. INDICATIONS-75 YO PATIENT PRESENTED WITH WEAR AND EARLY OSTEOLYSIS AND PAIN AFFECTING THE RIGHT HIP. RADIOGRAPHS REVEALED SEVERE POLYETHYLENE WEAR OVER THE RECALLED POLYETHYLENE LINERS. THE PATIENT WAS TAKEN TO THE RECOVERY AREA IN STABLE CONDITION WITH NO COMPLICATIONS NOTED ABOUT THE SURGERY. HOSPITAL CARE TIME: ADMITTED ON (B)(6)2023/DISCHARGED ON (B)(6) 2023. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 17105811 ↗
• InjuryApr 27, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2012. THE PATIENT WAS REVISED DUE TO POLY WEAR AND A NEW EXACTECH LINER AND HEAD WERE IMPLANTED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16822487 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, WHO HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011, BECAME INFECTED. A SURGEON ASSUMED CARE ON (B)(6) 2011. THEY UNDERWENT A POLYETHYLENE EXCHANGE AND AN I AND D OF THE LEFT HIP. THE INFECTION WAS CURED. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 16728745 ↗