Novation 138-36-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862024886), received between Mar 21, 2023 and Mar 10, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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-2132-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 10 MONTHS POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE GXL LINER RECALL. THE REP WAS NOT AWARE OF ANY SYMPTOMS LEADING UP TO THE REVISION SURGERY AND DID NOT ASK THE SURGEON. THE SURGEON'S PA STATED THE PATIENT WAS WANTING TO HAVE THE GXL LINER EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21563540 ↗
• InjuryAug 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, EFFUSION, ANTALGIC GAIT, INSTABILITY, INFLAMMATION AND EMOTIONAL DISTRESS . POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Emotional Changes; Inflammation; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20087103 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 124 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 19643996 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 135 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: Failure of Implant; Insufficient Information

  MAUDE report 19298823 ↗
• InjuryNov 8, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2014, AND THEN APPROXIMATELY 4 YEARS, 9 MONTHS LATER EXPERIENCED A REVISION SURGERY ON (B)(6) 2019. REVISION OPERATIVE REPORT OF (B)(6) 2019: PREOPERATIVE DIAGNOSES: 1. FAILED LEFT TOTAL HIP ARTHROPLASTY WITH SEVERE CYSTIC OSTEOLYSIS AND EXTREME POLYETHYLENE WEAR. 2. SUBACUTE POSTERIOR PELVIC RING FRACTURE THROUGH CYSTIC OSTEOLYSIS. 3. SUBACUTE ANTERIOR PELVIC RING FRACTURE THROUGH CYSTIC OSTEOLYSIS. PROCEDURE PERFORMED: 1. REVISION LEFT TOTAL HIP ARTHROPLASTY ¿ACETABULAR COMPONENT REVISED ONLY VIA SEPARATE INCISION. 2. OPEN REDUCTION, INTERNAL FIXATION OF LEFT POSTERIOR PELVIC RING FRACTURE VIA SEPARATE INCISION. 3. OPEN REDUCTION, INTERNAL FIXATION OF LEFT ANTERIOR PELVIC RING FRACTURE VIA SEPARATE INCISION. THROUGHOUT THE POSTERIOR ASPECT OF THE HIP JOINT, PARTICULARLY AROUND THE POSTERIOR COLUMN, THERE WAS REACTIVE MATERIAL CONSISTENT WITH CYSTIC OSTEOLYSIS AND PARTICULATE DISEASE. THE POSTERIOR PELVIC BONE WAS VERY THIN. THE POLYETHYLENE IN THE ACETABULUM. IT WAS SEVERELY ECCENTRICALLY WORN. THERE WAS AN ANTERIOR LIP AND THIS LIP WAS PARTIALLY DAMAGED AND PARTIALLY DESTROYED DUE

  Patient problems: Osteolysis

  MAUDE report 18095988 ↗
• InjuryOct 9, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2017. THE PATIENT WAS REVISED DUE TO THE RECALL OF THE GXL LINER. THE SURGEON REVISED THE LINER AND HEAD. 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: Failure of Implant; Insufficient Information

  MAUDE report 17902033 ↗
• InjuryAug 2, 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) 2009. THEY UNDERWENT LEFT HIP REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY 11 YEARS 1 MONTH POST PRIMARY PROCEDURE. 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

  MAUDE report 17446733 ↗
• InjuryJul 26, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  REVISION OPERATIVE REPORT: POSTOPERATIVE DIAGNOSIS(ES): FAILED LEFT TOTAL HIP ARTHROPLASTY. REVISION OF FEMORAL AND ACETABULAR COMPONENTS. SHE WAS SEEN AND EVALUATED AND BEING FOLLOWED FOR A PERIOD OF TIME FOR ACCELERATED POLYWEAR, PATIENT PRESENTED WITH PAIN. LARGE UNCONTAINED CYSTIC DEFECT AT THE POSTERIOR ASPECT OF THE FEMUR AND AT THE MEDIAL ASPECT. THIS WAS DEBRIDED AND APPEARED TO BE MEMBRANE CONSISTENT WITH OSTEOLYSIS. LARGE CYSTIC OSTEOLYTIC LESIONS CIRCUMFERENTIAL TO THE FEMUR. SIGNIFICANT WEAR AND DISCOLORATION OF THE PLASTIC WITH GROSS FAILURE AT THE POSTERIOR ASPECT WHERE THE LIP WAS POSTERIORLY. PATIENT TOLERATED THE PROCEDURE WELL, WAS TRANSPORTED TO RECOVERY ROOM IN STABLE CONDITION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information; Osteolysis; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 17398233 ↗
• InjuryMar 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE FEMALE PATIENT HAD AN INITIAL LEFT THA ON 10/14/2010. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY AND FOR YEARS AFTER THE REPLACEMENT SURGERIES, THE PATIENT'S EXACTECH HIP DEVICES PERFORMED AS EXPECTED. THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO POLYETHYLENE LINER WEAR RESULTING IN PERIPROSTHETIC OSTEOLYSIS AND REACTIVE SYNOVITIS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

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

  MAUDE report 16582459 ↗

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-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-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-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-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-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-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-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-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-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-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-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