Novation 138-32-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862024732), received between Mar 23, 2020 and May 11, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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-2132-2021 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Naturally Worn

  ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A TOTAL RIGHT HIP REPLACEMENT AND WAS IMPLANTED WITH A NOVATION GXL ACETABULAR LINER. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 2 YEARS AND 2 MONTHS POST THE INITIAL TOTAL HIP ARTHROPLASTY DUE TO PROSTHESIS WEAR AND/OR LOOSENING. IT IS UNCLEAR IF THE COMPETITOR FEMORAL STEM WAS FOUND LOOSE AT THIS REVISION OR IF THE LOOSENING IS REFERRING TO THE EXACTECH ACETABULAR CUP. THE PATIENT REPORTEDLY CONTINUES TO EXPERIENCE SEVERE PAIN AND DISCOMFORT IN THEIR HIP.

  Patient problems: Discomfort; Osteolysis; Pain

  MAUDE report 25141530 ↗
• InjuryJul 21, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS AND 2 MONTHS POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT AND WENT IN FOR REVISION SURGERY WHERE THE POLY WAS FOUND BROKEN INTO MANY PIECES. THE SURGEON PULLED OUT THE EXACTECH ACETABULAR AND WENT BACK IN WITH A COMPETITOR CUP AND LINER. THE SURGEON LEFT THE EXACTECH STEM IN, AND IMPLANTED A NEW FEMORAL HEAD TO MATCH UP TO THE COMPETITOR ACETABULAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 22555184 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19713801 ↗
• InjuryJun 6, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 72 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS, WEAR, JOINT PAIN, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. 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; Loss of Range of Motion

  MAUDE report 19479776 ↗
• InjuryMar 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)(2023, APPROXIMATELY 8 YEARS, 5 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18956200 ↗
• InjuryMar 13, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2021 APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18892852 ↗
• InjurySep 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND 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: FAILED LEFT TOTAL HIP REPLACEMENT (FAILED CUP). FINDINGS: FEMORAL STEM WAS STABLE AND WELL FIXED. SEVERE POLY WEAR AND OXIDATION. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE HIP JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THIS WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PESUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. PATIENT REVERSED FROM ANESTHESIA AND SENT TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 17832385 ↗
• InjuryAug 8, 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) 2014. APPROXIMATELY, (B)(6) YEARS AND (B)(6) 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 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: Discomfort; Failure of Implant; Insufficient Information; Pain

  MAUDE report 17478725 ↗
• InjuryNov 10, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED AN 85 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6), 2014, WAS REVISED ON (B)(6), 2022, APPROXIMATELY 8 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON PULLED THE WORN COMPONENTS AND REPLACED WITH XLE EXTENDED COVERAGE LINER & DELTA OPTION HEAD (32). ¿WAIT AND SEE¿, WAS THE FINAL OUTCOME NOTED FOR THE PATIENT FOLLOWING THE EVENT. NO PRODUCTS ARE AVAILABLE FOR RETURN AS THE HOSPITAL TAKES THEM TO THE LAB. NO FURTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777415 ↗
• InjuryOct 4, 2022Fracture; Device Dislodged or Dislocated; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Device Dislodged or Dislocated; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A FEMALE PATIENT, INITIAL RIGHT HIP CONNEXION GXL ACETABULAR LINER IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019, APPROXIMATELY 3 YEARS 1 MONTH POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Fall; Joint Dislocation; Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15540884 ↗
• InjuryFeb 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TEN YEARS POST INITIAL THA, THIS FEMALE PATIENT'S POLY BROKE. PATIENT WAS REVISED TO AN XLE LINER. THERE WERE NO BROKEN PIECES FELL IN THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAY WERE UNABLE TO OBTAIN. DEVICE IS NOT AVAILABLE FOR EVALUATION AS DEVICE WAS KEPT BY HOSPITAL AND THROWN AWAY.

  Patient problems: Failure of Implant

  MAUDE report 13565337 ↗
• InjuryJul 26, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YRS POSTOP THE INITIAL RTHA, THIS (B)(6) Y/O FEMALE PATIENT PRESENTED WITH A GROSSLY UNSTABLE HIP. SURGEON BELIEVES IT WAS BECAUSE OF SIGNIFICANT POLY WEAR. PATIENT RECEIVED AN XLE VERSION OF THE SAME POLY. THE DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 12224896 ↗
• InjuryJul 12, 2020Appropriate Device Problem Term/Code Not Available

  AS REPORTED, APPROXIMATELY 9 YRS AND 5 MOS. POSTOP THE INITIAL IMPLANT, THIS FEMALE, (B)(6) YEARS OLD, WAS REVISED. THE SURGEON REMOVED THE LEFT SIDE LINER AND REPLACED IT WITH THE SAME ONE. HE UPSIZED THE HEAD BY 3.5MM TO GIVE THE PERSON BETTER STABILITY. PATENT WAS REVISED TO 10 DEGREE LINER, 32MM FEMORAL HEAD AND ADAPTER 16/18-12/14, +3.5MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. HOSPITAL THREW AWAY DEVICES, NOT RETURNING.

  Patient problems: No Code Available

  MAUDE report 10262060 ↗
• InjuryMar 23, 2020Naturally Worn; Naturally Worn

  AS REPORTED, PATIENT WAS REVISED NOW FOR CLEAR WEAR. PATIENT FOUND TO HAVE CLEAR METALLOSIS. ATTEMPT WAS TO EXCHANGE TO NEW XLE LINER, BUT STABILITY STILL CONCERN. IN ORDER TO AVOID CHANGING CUP/FEMORAL VERSION, DECISION WAS TO CEMENT ALL POLY CUP INSIDE CUP AT THE CORRECT VERSION, AND WE PROVIDED A DELTA OPTION HEAD FOR STEM. PATIENT STABLE.

  Patient problems: Failure of Implant

  MAUDE report 9867919 ↗

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-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-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-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-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-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-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-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-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-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-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