Novation 132-36-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10885862023421), received between Sep 21, 2020 and Dec 1, 2025 — classified as 28 injuries.

The most frequently reported specific device problem is “Naturally Worn” (27 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. How this data works · Data updated Oct 13, 2026.

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-1729-2022 · 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-2122-2021 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1 YEAR AND 1 MONTH POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. A COMPETITOR ACETABULAR AUGMENT WITH BONE GRAFTING CEMENT WAS USED WITH A NEW VIT E EXACTECH LINER AND HEAD. THERE WERE NO ISSUES. THE HIP WAS STABLE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 23681236 ↗
• InjuryNov 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND STIFFNESS. UPON PHYSICAL AND X-RAY EXAMINATION, BOTH HIPS SHOW POLY THINNING, INDICATING POLY WEAR AND OSTEOLYSIS BEHIND THE ACETABULAR CUP IMPLANT, WHERE THE ACETABULAR SCREW IS LOCATED. A CT SCAN WAS ALSO OBTAINED, WHICH SHOWS THE SAME RESULTS. THERE IS CONCERN FOR LOOSENING OF THE ACETABULAR CUP IMPLANT. THE POLY LINER IS PART OF THE RECALL. THE SURGEON PLANNED FOR HEAD/LINER EXCHANGE WITH AUGMENTATION OF BONE GRAFT BEHIND THE CUPS VS. A FULL CUP REVISION. THE HIP JOINTS WERE EXPOSED, DEBRIDED, THE FEMORAL HEAD REMOVED. THEY CHECKED THE FEMORAL STEM FOR STABILITY, REMOVED THE ACETABULAR POLY LINER, REMOVED THE 6.5 X 30MM SCREW, AND THEN INJECTED A BONE VOID FILLER SUBSTITUTE INTO THE BONE DEFECT BEHIND THE CUP. THE HIP JOINTS WERE IRRIGATED AND DEBRIDED WELL. SURGEON IMPLANTED NEW POLY ACETABULAR LIPPED 40MM VITAMIN E LINER AND A 40MM +0 FEMORAL HEAD. THE PATIENT LEFT THE OR STABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 23571540 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 53 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AND OSTEOLYSIS, AND TISSUE DAMAGE. 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; Pain

  MAUDE report 20070896 ↗
• InjuryAug 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT AND THEN APPROXIMATELY 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION. REVISION OP REPORT NOTED THAT THE PATIENT'S TOTAL HIP ARTHROPLASTY WAS COMPLICATED BY A FRACTURE OF THE FEMORAL SHAFT WHICH ESSENTIALLY HEALED IN A MALUNION WITH SUBSIDENCE OF THE STEM AND OBVIOUS LOOSENING TO THE ACETABULUM. THE SURGEON NOTED THAT THE STEM WAS GROSSLY UNSTABLE, HOWEVER, THEY DID NOT SEE ANY ACTUAL FAILURE OF THE STEM SUCH AS A FRACTURE. THERE WERE MULTIPLE SCUFFS WITH THE POLYETHYLENE, WHICH WAS REMOVED. INSPECTION OF THE PATIENT'S FEMUR DID NOT FIND ANY INSTABILITY WITH PALPATION OF THE GREATER TROCHANTER, NOR ANY DEFINITE ACUTE FRACTURE LINES. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS FRACTURE WHICH APPEARED TO BE HEALED ON X-RAYS. HOWEVER, THERE WAS WIDENING IN THE METAPHYSEAL REGION. THE FRACTURE HAD BEEN LOW, ALMOST EXITING NEAR THE TIP OF THE STEM; IT WAS JUST PROXIMAL TO THE TIP OF THE STEM. NO SURGICAL COMPLICATIONS. PATIENT OUTCOME WAS NOT REPORTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Malunion of Bone; Pain; Swelling/ Edema

  MAUDE report 19927433 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT: THE PATIENT HAS RETAINED AN ATTORNEY WHO CONTACTED EXACTECH TO TOLL THE STATUTE OF LIMITATIONS AND PRESERVE THE PATIENT¿S ABILITY TO FILE A LAWSUIT IN THE FUTURE. BECAUSE THE PATIENT HAS RETAINED AN ATTORNEY TO PRESERVE THE RIGHT TO FILE A LEGAL ACTION SEEKING REDRESS FOR ALLEGED PAST SERIOUS INJURY OR FUTURE SERIOUS INJURY ALLEGEDLY STEMMING FROM THE USE OF AN EXACTECH DEVICE, THE PATIENT APPEARS TO ALLEGE THAT THERE IS A PURPORTED DEFICIENCY IN THE DEVICE AND/OR THAT THE PATIENT HAS INCURRED SERIOUS INJURY AS A RESULT OF THE DEVICE. THE EBI SEARCH LISTED TWO 132-36-53 LINERS, SERIAL #S (B)(6) AND (B)(6), FOR THIS PATIENT'S INVOICE. UNABLE TO DETERMINE WHICH LINER WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19833786 ↗
• InjuryJul 25, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS AFTER A LEFT 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 19833404 ↗
• InjuryJul 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022 132-36-53 - NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS SERIAL: (B)(6). 510K: K070479. UDI: (B)(4) PRODUCT CODE: JDI, LPH, LWJ, LZO, MEH X-RAY: NO OPERATIVE NOTES: NO. CONCOMITANT DEVICES: 4525626 162-00-05 - NECK PRESERVING STEM, STD OFFSET PLASMA SZ 5. 4767183 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM. 4769004 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3. 4775301 180-65-30 - ALTEON 6.5MM SCREW, 30MM.

  Patient problems: Insufficient Information

  MAUDE report 19706081 ↗
• InjuryJul 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 135 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR WITH ACETABULAR OSTEOLYSIS, NECROTIC BONE, PAIN, AND SUFFERING. 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; Osteolysis; Pain

  MAUDE report 19694901 ↗
• InjuryJun 7, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 68 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LIMITED ROM, LOSS OF MOBILITY, ANXIETY, AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Implant Pain; Joint effusion; Loss of Range of Motion

  MAUDE report 19481560 ↗
• InjuryMay 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 8 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT SURGERY THE PATIENT EXPERIENCED SEPTIC INFECTION AND UNDERWENT A REVISION PROCEDURE. A POST OPERATIVE REVISION REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED INFECTED RIGHT HIP REPLACEMENT, FAILED WITH PERSISTENT INFECTION. INTRAOPERATIVELY THE SURGEON OBSERVED HETEROTOPIC OSSIFICATION THROUGHOUT THE HIP AND REMOVED NECROTIC DAMAGED TISSUES. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Failure of Implant; Implant Pain; Medical device site infection; Scar Tissue

  MAUDE report 19424379 ↗
• InjuryMay 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, AND POSTEROSUPERIOR IMPINGEMENT. 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: Failure of Implant; Joint Impingement; Osteolysis; Synovitis

  MAUDE report 19404237 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 78 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SEVERE PAIN, DIFFICULTIES WITH MOBILITY, LIMITED PHYSICAL ACTIVITY AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19330831 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 148 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Swelling/ Edema

  MAUDE report 19310042 ↗
• InjuryMay 2, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL THA DONE IN 2012. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO POLY WEAR, AND THE HEAD AND LINER WERE REMOVED . NO ISSUES.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19228583 ↗
• InjuryApr 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER INITIAL IMPLANT. OP REPORT ; POSTOPERATIVE DIAGNOSIS; POLY WEAR. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 19105077 ↗
• InjuryMar 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP IMPLANT ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Emotional Changes; Failure of Implant; Pain

  MAUDE report 18935921 ↗
• InjuryMar 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT HIP IMPLANT ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 8 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: POLYETHYLENE WEAR AND OSTEOLYSIS RELATED TO LEFT INTERNAL HIP PROSTHESIS. THE ACETABULAR LINER WAS FOUND TO BE WORN. THE FEMORAL COMPONENT WAS FOUND TO BE WELL-FIXED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE PATIENT WAS TRANSFERRED TO THE BED AND THEN 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; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 18896925 ↗
• InjuryJan 29, 2024Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT A 68 YO MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6), 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2024, APPROXIMATELY 6 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON PERFORMED A HEAD AND LINER EXCHANGE DUE TO THE PREMATURE WEAR OF A NOVATION GXL LINER. HE REVISED TO AN XLE LINER AND BIOLOX DELTA OPTION ADAPTER AND HEAD. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS WERE AVAILABLE AS THEY WERE SENT TO LEGAL. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Insufficient Information; Loss of Range of Motion; Osteolysis; Scar Tissue

  MAUDE report 18602639 ↗
• InjuryNov 14, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2008. APPROXIMATELY 14 YEARS AND 5 MONTHS 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 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18130889 ↗
• InjuryJul 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN ORIGINAL PRIMARY TOTAL HIP REPLACEMENT, THEN APPROXIMATELY SEVEN YEARS POST INITIAL THA, THE 72 Y/O MALE PATIENT RETURNED TO SURGEON'S OFFICE COMPLAINING ABOUT THEIR PRIMARY HIP PAIN AND DISSATISFACTION. UPON EXAMINATION AND IMAGING THE POLY LINER SHOWED WEAR AND IS A PRODUCT ASSOCIATED WITH THE RECALL. THE PATIENT UNDERWENT REVISION RIGHT THA WHERE THE FEMORAL HEAD AND POLY LINER WERE SWAPPED. A NEW VITAMIN E LINER, CERAMIC HEAD AND BIOLOX OPTION ADAPTER +7MM WERE IMPLANTED. THE PATIENT LEFT THE OPERATING ROOM (OR) STABLE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT IMAGES AND X-RAY 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 17401807 ↗
• InjuryJun 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 1 MONTH 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: WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT FINDINGS: ECCENTRIC POLYETHYLENE WEAR. THERE WAS SIGNIFICANT SYNOVITIS AND DETACHMENT OF THE POSTERIOR STRUCTURES. A STERILE COMPRESSIVE DRESSING WAS APPLIED. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17216420 ↗
• InjuryApr 20, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 56 YO MALE PATIENT, WHO HAD A RIGHT THA ON (B)(6) 2017, PRESENTED BACK TO THE SURGEON WITH COMPLAINTS ABOUT THEIR THA. UPON EXAMINATION, THE PATIENT HAD AN EXACTECH PRIMARY TOTAL HIP IN. THE PATIENT PRESENTED WITH PAIN, STIFFNESS, AND DISSATISFACTION WITH THEIR RIGHT TOTAL HIP. THE NOVATION GXL LINER WAS RECALLED, AND THE CUP COMPONENT SHOWED A LESION OR BONE DEFECT BEHIND THE CUP. THE PATIENT HAD REVISION THA SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THEY UNDERWENT AN ACETABULAR POLY LINER SWAP AND A FEMORAL HEAD SWAP INCLUDING BONE GRAFT INTO THE ACETABULUM. THERE WAS A 15-30 MINS SURGICAL DELAY DURING THE PROCEDURE AS IT TOOK EXTRA TIME TO APPLY BONE VOID FILLER INTO THE ACETABULUM. THE EVENT WAS NOT RELATED TO ANY BREAKAGE OF DEVICE. THE PATIENT LEFT THE OR STABLE. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 16781681 ↗
• InjuryJan 4, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO PAIN. THE SURGEON'S INTRAOPERATIVE FINDINGS NOTED POLYETHYLENE WEAR. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16095871 ↗
• InjuryOct 18, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT HIP WAS REVISED 6 YEARS POST OP DUE TO POLYETHYLENE WEAR. X-RAY REVEALED ¿EVIDENCE OF SIGNIFICANT POLYETHYLENE WEAR¿ AND ¿EVIDENCE OF OSTEOLYSIS BEHIND THE SOCKET.¿ DEFECTIVE GXL LINER AND FEMORAL HEAD WERE REMOVED, AND SHE WAS IMPLANTED WITH A NEW VITAMIN E 56/36 +10 DEGREE NOVATION XLE ACETABULAR LINER AND A 36 MM BIOLOX DELTA FEMORAL HEAD.

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

  MAUDE report 15626386 ↗
• InjuryJun 13, 2022Naturally Worn; Naturally Worn

  AS REPORTED, PATIENT HAD A TOTAL HIP IMPLANT. COMPONENTS OF THIS HIP REPLACEMENT SYSTEM HAVE A RECALL NOTICE ADVISING PHYSICIANS OF EARLY WEAR AND TO EVALUATE PATIENTS WITH X-RAYS TO DETERMINE IF EARLY WEAR IS AFFECTING THE PATIENTS IMPLANT. IT IS, A TOTAL HIP REVISION IS TO BE CONSIDERED, THIS PATIENT HAD A TOTAL HIP REVISION DUE TO THE COMPONENTS OF THE HIP IMPLANTS PLACED INITIALLY IN 2019. THE EVENT WAS REPORTED DIRECTLY TO FDA UNDER MEDWATCH# MW5109455.

  Patient problems: Failure of Implant

  MAUDE report 14676374 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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
• 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