Novation 140-36-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862537317), received between Jun 22, 2023 and Oct 28, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF PREMATURE INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 2, 36 MM). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, THE CYSTS IN THE CUP BED WERE CURED AND FILLED USING HYDROXYAPATITE + CALCIUM (CERAMIC BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED.

  Patient problems: Fluid Discharge

  MAUDE report 20550258 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED LIVING WITH AN ADULTERATED, MISBRANDED, DEFECTIVE DEVICE IMPLANTED. FUTURE REVISION SURGERY MAY BE REQUIRED FOR POLYETHYLENE WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19290085 ↗
• InjuryApr 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2022 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 2 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19011057 ↗
• InjuryMar 27, 2024Loss of Osseointegration; Naturally Worn; Loss of Osseointegration; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT HIP REVISION ON (B)(6)2022, AND THEN EXPERIENCED A SECOND REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 MONTHS AFTER REVISION SURGERY. REVISION OPERATIVE REPORT OF (B)(6) 2023 POSTOPERATIVE DIAGNOSIS: MECHANICAL LOOSENING OF INTERNAL RIGHT HIP PROSTHETIC JOINT, INITIAL ENCOUNTER. THE HIP WAS DISLOCATED WITH RELATIVE EASE AND THE FEMORAL HEAD WAS REMOVED FROM THE TRUNNION WITH NO DAMAGE. THERE WERE 2 AREAS OF OSTEOLYSIS NOTED 1 AT THE DOME. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE PATIENT OPTED TO BED TAKEN TO RECOVERY ROOM STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 18989871 ↗
• InjuryNov 8, 2023Naturally Worn; Naturally Worn

  MDR REPORT #: MW5146332. IT WAS REPORTED VIA MEDWATCH BY A FEMALE PATIENT THAT THEY STARTED HAVING HIP PAIN AFTER 3 YEARS. LINER HAD PREMATURE WEAR AND FAILED CAUSING THE PAIN AND A REVISION SURGERY 4 YEARS LATER. DEVICES WILL NOT BE RETURNING - PATIENT REQUESTED EXPLANTS.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 18091630 ↗
• InjuryAug 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S RIGHT HIP WAS REVISED. THE SURGEON REVISED THE LINER TO A NEW XLE LINER AND THE HEAD FROM A COCR TO A BIOLOX OPTIONS HEAD. REASON FOR THE REVISION IS UNKNOWN, POSSIBLY DUE TO THE RECALL. THE PATIENT WAS STABLE WITH ORIGINAL IMPLANTS. DOCTOR REMOVED THE HEAD AND THEN HE LINER. HE CHECKED THE STABILITY OF THE CUP AND THE STEM BOTH WERE WELL FIXED. HE THEN IMPLANTED A NEW G2 XLE LINER AND A BIOLOX OPTIONS 36 +3.5 HEAD. THE PATIENT ORIGINALLY HAD A 35 +3.5 COCR HEAD IN WITH A G2 XLE NEUTRAL LINER. THE PATIENT WAS REDUCED AND WAS STABLE AT TIME OF IMPLANTATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR IMAGES OBTAINED. PRODUCT NOT RETURNING, DOCTOR KEPT IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 17641672 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 73 YEAR OLD MALE PATIENT, WHO WAS INITIALLY IMPLANTED IN (B)(6) 2017, AND HAD A REVISION ON (B)(6) 2022, UNDERWENT A 2ND REVISION PROCEDURE ON AN UNKNOWN DATE. REASON FOR THE REVISION NOT REPORTED. RECALLED POLY INDICATED, WHICH WAS NOT CONFIRMED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. THE HOSPITAL KEPT THE DEVICES. NO DEVICE IMAGES OR PATIENT X-RAYS PROVIDED. NO FURTHER INFORMATION. ON (B)(6) 2022 REVISION REPORTED UNDER 1038671-2023-00083.

  Patient problems: Insufficient Information

  MAUDE report 17611264 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE 68 Y/O PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2023. APPROXIMATELY 4 MONTHS AFTER THE REVISION THE PATIENT HAD A SYNOVECTOMY ON (B)(6) 2023 DUE TO CONTINUED GROIN PAIN. 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. SYNOVECTOMY OP REPORT ON (B)(6) 2023. PROCEDURE: ARTHROTOMY WITH SYNOVECTOMY HIP JOINT. POST-OP DIAGNOSIS: POLYETHYLENE WEAR AND OSTEOLYSIS S/P LEFT TOTAL HIP ARTHROPLASTY OF HIP REVISION OF (B)(6) 2023. A NEW MRI REVEALED A PERSISTING AREA OF SYNOVITIS MEDIALLY UNDER THE RECTUS FEMORIS AND ERODING THE PSOAS TENDON. HE WAS INDICATED FOR ADDITIONAL SYNOVECTOMY. INITIAL DISSECTION WAS PERFORMED MEDIAL TO THE RECTUS FEMORIS TO IDENTIFY THE PROXIMAL MEDIAL BORDER OF THE SYNOVIAL MASS. THEN THEY WORKED FROM INSIDE THE PREVIOUS ARTHROTOMY IN A MEDIAL DIRECTION TO IDENTIFY AND REMOVE THE RESIDUAL SYNOVIAL MASS AND PSOAS BURSITIS REGION. REMOVAL OF ALL OF THE SYNOVIAL MASS WAS ASSURED. THE PATIENT EMERGED FROM ANESTHESIA A

  Patient problems: Pain; Synovitis

  MAUDE report 17181209 ↗

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