Novation 142-36-62Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862537638), received between Jan 18, 2023 and May 20, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K173583); 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. Dec 31, 2024Class IIOpen, Classified

   Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

   Z-1166-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 80 MONTHS AFTER BILATERAL TOTAL HIP ARTHROPLASTY, A PATIENT PRESENTED BACK TO DOCTOR'S OFFICE WITH COMPLAINTS OF PAIN, STIFFNESS AND DISSATISFACTION WITH THE RIGHT HIP. SUBSEQUENTLY, THE DOCTOR NOTED THAT THE PATIENT TECHNICALLY HAD A RECALLED POLYETHYLENE. AS A RESULT, THE PATIENT WAS SCHEDULED FOR A RIGHT HIP REVISION SIX DAYS LATER. IT WAS NOTED THAT DURING THE REVISION PROCEDURE THE PATIENT UNDERWENT AN ACETABULAR POLYETHYLENE SWAP AND FEMORAL HEAD REPLACEMENT. INTRAOPERATIVELY, IT WAS NOTED THAT THE FIRST POLYETHYLENE REPLACEMENT COMPONENT FAILED TO LOCK INTO THE ACETABULAR COMPONENT PROPERLY. IT WAS REMOVED; THE REMAINING BONE AND SOFT TISSUE WERE REMOVED AROUND THE RIM OF THE CUP AND THE SECOND POLYETHYLENE WAS LOCKED IN PROPERLY. POST OPERATIVELY IT WAS NOTED THERE WAS A SURGICAL DELAY/PROLONGATION DUE TO FURTHER DISSECTION AND DEBRIDEMENT AROUND THE ACETABULAR RIM FROM THE FIRST REPLACEMENT NOT LOCKING IN PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT IMPACT DUE TO THE SURGICAL DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES OF THE POLYETHYLENE EXPLANTS WERE PROVIDED. NO OPERATIVE REPORTS OR MEDICAL RECO

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 22054684 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN EXACTECH HIP PROSTHESIS IMPLANT IN 2020. DUE TO PREMATURE INLAY WEAR AND THE COMPANY'S RECALL, THE REVISION TOOK PLACE ON (B)(6)2024 WITH THE INLAY BEING CHANGED TO A SPECIALLY APPROVED INLAY. DUE TO SUBLUXATIONS AND COMPLAINTS, ANOTHER CHANGE TOOK PLACE ON (B)(6) 2024. THE PATIENT WAS PRESENTED TO OUR EMERGENCY ROOM AGAIN ON (B)(6) 2024 WITH LOCAL SIGNS OF INFECTION FROM THE FOLLOW-UP TREATMENT. EMERGENCY DIAGNOSTICS REVEALED A HIGH SUSPICION OF AN EARLY INFECTION, SO THAT ANOTHER REVISION WAS CARRIED OUT. THE SUSPICION OF INFECTION WAS CONFIRMED AND AN ATTEMPT WAS MADE TO PRESERVE THE PROSTHESIS BY CHANGING THE INLAY AND THE HEAD, EXTENSIVE DEBRIDEMENT, JET LAVAGE WITH GRANUDACYN AND TAKING SAMPLES FOR MICROBIOLOGICAL TESTING. A STAPH. AUREUS INFECTION WAS DETECTED HERE. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED FOR 14 DAYS IN ACCORDANCE WITH THE ANTIBIOGRAM, WHICH WERE THEN ORALLY ADMINISTERED FOR A FURTHER 10 WEEKS. THE PATIENT WAS ABLE TO BE DISCHARGED BACK TO THE AHB FACILITY. (B)(6) 2024 REVISION REPORTED UNDER MDR# 1038671-2024-01747. (B)(6) 2024 REVISION REPORTED UNDER MDR# 1038671-2024-04818.

  Patient problems: Bacterial Infection

  MAUDE report 21210003 ↗
• InjuryJun 21, 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 8 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS OSTEOLYSIS CONTINUED FROM A PREVIOUS REVISION AND DISCOMFORT. INITIAL SURGERY AND 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: Ambulation or Postural Difficulties; Discomfort; Osteolysis

  MAUDE report 19582375 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3 YEARS POST INITIAL THA, THE 80 Y/O MALE PATIENT HAD A REVISION NEEDED DUE TO CHRONIC INFECTION. THE PATIENT WAS SEEN FOR PAIN AND SWELLING LAST WEEK WITH DRAINAGE. PATIENT HAD LINER AND HEAD REMOVED AND ARTHROTOMY AND IRRIGATION WITH DEBRIDEMENT DONE. A NEW EXACTECH LINER AND HEAD IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS NOT UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE INFECT HIP IMPLANTS.

  Patient problems: Implant Pain; Inflammation; Medical device site infection; Unspecified Infection

  MAUDE report 19355844 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS REVISED TO A NOVATION GXL ON (B)(6) 2021. THE PATIENT HAS NOT BEEN REVISED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17808350 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT HIP REVISION IMPLANT DATE, (B)(6) 2022, UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 MONTHS POST THE PRIOR PROCEDURE. HIS INCISION WAS DRAINING. THE MALE PATIENT WAS BROUGHT BACK FOR AN IRRIGATION AND DEBRIDEMENT OF THE RIGHT HIP. THE HIP WAS DISLOCATED, THE FEMORAL HEAD REMOVED AND ATTENTION TURNED TO THE CUP. THE LINER WAS REMOVED WITH THE HELP OF A BONE SCREW. THE HIP WAS WASHED THOROUGHLY AND NEW XLE GROUP 2 LIPPED POLY, 36+3.5 BIOLOX HEAD, AND 10 CC OF INTERSEP WERE IMPLANTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED. THE HOSPITAL DISCARDED IT. NO FURTHER INFORMATION.

  Patient problems: Fluid Discharge; Inflammation

  MAUDE report 16195618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173583. One submission often covers many models, so check the product and lot details in each record.

• Z-1165-2025 · Dec 31, 2024 · Open, Classified
  AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-2
• Z-0577-2024 · Nov 21, 2023 · Open, Classified
  AcuMatch Hip System, Catalog Number 142-32-27