Novation 136-32-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862024299), received between Apr 26, 2021 and Jan 13, 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. 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-2127-2021 · Root cause: Unknown/Undetermined by firm · Recall details · 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.

• InjuryJan 13, 2026Structural Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEAR(S) AND 9 MONTH(S) POST IMPLANTATION OF A RIGHT TSA, THE PATIENT PRESENTED WITH INFECTION. THE PATIENT HAD RTSA WITH LOOSE GLENOSPHERE + METAGLENE COMPONENT WITHOUT BROKEN HARDWARE AND SCAPULAR NOTCHING. PLAN FOR REVISION WITH ANTIBIOTIC SPACER. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION IN EARLY 2019 FOLLOWED WITH ANTIBIOTIC SPACER PROCEDURE LATER THAT YEAR. IMPLANTATION OF ANTIBIOTIC DELIVERY SYSTEM DUE TO POSITIVE MRSA SCREEN. PATIENT HAS CLEARED INFECTION AND DESIRES CONVERSION BACK TO A REVERSE TSA. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Bone Notching; Failure of Implant; Unspecified Infection

  MAUDE report 24056322 ↗
• InjuryApr 10, 2025Naturally Worn; Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT A REVISION OF THEIR HIP LINER. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Cyst(s); Insufficient Information; Osteolysis

  MAUDE report 21813853 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND MINOR OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP

  Patient problems: Osteolysis

  MAUDE report 20877797 ↗
• InjuryOct 8, 2024Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCAN SHOWED A CLEAR DECENTRATION OF BOTH PROSTHESIS HEADS AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED SPECIALLY APPROVED INLAY (NOVATION XLE, +5 MM LATERALIZED LINER, GROUP 3, 36 MM I.D. REF 146-36-53, SN (B)(6). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM INTEGRITY OF THE SOCKET WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE SOCKET USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE REPLACEMENT OF THE PROSTHESIS HEAD.

  Patient problems: Osteolysis

  MAUDE report 20398393 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED FOR A CHECK-UP. THE X-RAY AND CT CHECK SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD, A SIGN OF OSTEOLYSIS IN THE ACETABULUM AN INLAY WEAR. THIS WAS POSSIBLE WHEN THE INLAY WAS CHANGED TO A VITD-HARDENED ONE ON (B)(6) 2024 SPECIALLY APPROVED INLAY (NOVATION XLE +5MM, LATERALIZED LINER, GROUP 3, 36 MM I.D., REF (B)(4), SN (B)(6)) BE VERIFIED. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED, CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19296677 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE COMPETENT AUTHORITIES, THE PATIENT WAS IMPLANTED WITH A HIP PROSTHETIC CUP FROM EXACTECH. AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED HERSELF FOR A CHECK-UP. THE X-RAY AND CT CHECK SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD, A SIGN OF OSTEOLYSIS IN THE ACETABULUM AN INLAY WEAR. THIS WAS POSSIBLE WHEN THE INLAY WAS CHANGED TO A VITD-HARDENED ONE ON APRIL 18, 2024 SPECIALLY APPROVED INLAY (NOVATION XLE, +5MM LATERALIZED LINER, GROUP 3, 36MM) BE VERIFIED. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED, CUP INTEGRITY AND THE REPLACEMENT OF THE PROSTHETIC HEAD.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19280961 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT 5.5 YEARS POST OP THIS PATIENT PRESENTED BACK TO THE SURGEONS OFFICE TO GET LEFT HIP PROSTHESIS FROM 2018 CHECKED. X-RAY CONTROL SHOWED A SLIGHT DECENTERING OF THE PROSTHESIS HEAD AND OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED ON (B)(6) 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRM SOCKET INTEGRITY WAS DETERMINED AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC CANCELLOUS BONE AND THE REPLACEMENT OF THE PROSTHETIC HEAD.

  Patient problems: Cyst(s); Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 18346422 ↗
• InjuryOct 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED, DUE TO THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT THAT IS 5 YRS POSTOP THE INITIAL THAT CAME IN TO HAVE THE HIP PROSTHESIS CHECKED. X-RAY CONTROL REVEALED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND UNUSUALLY COARSE OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF PREMATURE INLAY DETERIORATION. DIAGNOSIS THAT LED TO THE IMPLANTATION: PRIMARY COXARTHROSIS DURING THE REPLACEMENT OPERATION, THE SOCKET COMPONENT WAS COMPLETELY LOOSENED, SO THAT AFTER REMOVAL OF THE OLD CUP, SPA FIXATION AND SEALING, AND A COMPETITOR¿S DEVICES WERE IMPLANTED. DEVICE MAY BE RETURNED UPON POSSIBLE PATIENT CONSENT. SURGICAL REPORTS/X-RAYS ARE ALSO MADE AVAILABLE ON REQUEST.

  Patient problems: Failure of Implant

  MAUDE report 17859731 ↗
• InjuryMay 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL THA, PATIENT HAD A REVISION DUE TO POLYETHYLENE WEAR. PATIENT WAS REVISED TO A CC INLAY VITAMIN E, LAT Ø 36, GR. 3 CAT# 146-36-53 / SERIAL# (B)(6). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17019490 ↗
• InjuryAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A BFARM NOTIFICATION THAT 60 YO MALE PATIENT UNDERWENT A REVISION APPROXIMATELY 4 YEARS 9 MONTHS POST AN INITIAL HIP PROCEDURE, INITIAL IMPLANT ON (B)(6) 2017. AN INCREASED DECENTERING OF THE HEAD IN THE INLAY IMPRESSED WITH CLEARLY VISIBLE OSTEOLYSIS IN THE BONY INTERFACE AREA OF THE METAL SOCKET AS A SIGN OF A CLEAR INLAY WEAR STATED. PUNCTURE TEST ADMINISTERED ON (B)(6) 2022, PROVED THE ABSENCE OF INFECTION. INTRAOPERATIVELY, IT WAS VERIFIED SOLID BONY INTEGRATION, THE CHANGE OF THE INLAY TO A HIGHLY CROSS-LINKED INLAY (EXACTECH XLE), WITH CHANGE OF THE CLIP-ON HEAD AND A CURETTAGE AND SEALING OF CYSTS WITH ALLOGENEIC SPONGIOSA.

  Patient problems: Cyst(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293630 ↗
• InjuryMay 26, 2022Naturally Worn; Naturally Worn

  AS REPORTED, A (B)(6) MALE PATIENT HAD A SCHEDULE REVISION TO RIGHT HIP ON (B)(6) 2022 DUE TO GXL POLY WEAR. NO OTHER PATIENT INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14515149 ↗
• InjuryJun 1, 2021Naturally Worn; Naturally Worn

  AS REPORTED, IN THE COURSE OF THE CLINICAL-RADIOLOGICAL EXAMINATION OF THE X-RAY IMAGES, ONE POST-OPERATED FOR 3 YEARS IMPLANTATION, A (B)(6) Y/O MALE, INCREASED DECENTRATION OF THE HEAD IN THE INLAY WITHOUT OSTEOLYSIS AS A SIGN OF EXCESSIVE INLAY WEAR.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 11917972 ↗
• InjuryApr 26, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THE RADIOLOGICAL FINDINGS OF THE PATIENTS TREATED WITH THIS IMPLANT WERE CHECKED. AN INCREASED DECENTERING OF THE HEAD IN THE INLAY FOR 5 YEARS AFTER IMPLANTATION WAS A SIGN OF SIGNIFICANT INLAY WEAR.

  Patient problems: Failure of Implant

  MAUDE report 11729937 ↗
• InjuryApr 26, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THE RADIOLOGICAL FINDINGS OF THE PATIENTS TREATED WITH THIS IMPLANT WERE CHECKED. AN INCREASED DECENTRATION OF THE HEAD IN THE INLAY FOR 5 YEARS AFTER IMPLANTATION WITH SIMULTANEOUS OSTEOLYSIS IN THE INTERFACE OF THE METAL CUP WAS A SIGN OF SIGNIFICANT INLAY WEAR. SIMILAR RADIOLOGY FINDINGS WERE ALSO FOUND IN THIS PATIENT ON THE OPPOSITE SIDE; THIS CASE WAS ALSO REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11729803 ↗

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-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-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-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-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-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-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-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-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-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-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