OXINIUM 71343612Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010520449), received between Aug 11, 2017 and Jan 15, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K021673, K211176); 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A REVISION SURGERY ON (B)(6) 2023, PATIENT MET WITH HIS DOCTOR BECAUSE OF PAIN AND DISCOMFORT. SURGEON STATED THAT HE MAY BE GETTING ANOTHER REVISION. IT IS UNKNOWN HOW THIS ADVERSE HAS BEEN ADDRESSED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

  Patient problems: Discomfort; Pain

  MAUDE report 24077656 ↗
• InjuryMar 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A LEFT HIP THA FIRST REVISION HAD BEEN PERFORMED ON (B)(6) 2018 TO REPLACE A BHR RESURFACING SYSTEM DUE TO A METALLOSIS DIAGNOSIS, THE PATIENT SUSTAINED AN UNSPECIFIED COMPLICATION THAT MADE NECESSARY A SECOND REVISION ON (B)(6) 2020. DURING THIS PROCEDURE, FEMORAL HEAD AND ACETABULAR LINER WERE EXCHANGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16542401 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON (B)(6) 2020. A WASHOUT WAS PERFORMED AND THE OXINIUM FEM HD 12/14 36 MM XL/+12 AND R3 0 DEG XLPE ACET LNR 36MM X 58MM WERE EXCHANGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10782071 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A REVISION SURGERY ON (B)(6) 2020 DUE TO DISLOCATION, THIS WAS REPORTED ON (REPORTED PREVIOUSLY). THEN, PATIENT HAD HEAVY EXUDATION WOUND POST REVISION FOR INSTABILITY, SO PATIENT RECEIVED A WASHOUT AND DEBRIDEMENT WITH SALINE, IODINE AND PEROXIDE. THE R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM AND THE OXINIUM FEM HD 12/14 36 MM XL/+12 WERE REMOVED. SHELL AND STEM RETAINED. WOUND WASHED AND IRRIGATED. NEW IMPLANTS OF THE SAME SIZING WERE IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10693329 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE HEAD AND THE LINER DUE TO E.COLI IN THE WOUND. A THOROUGH WASHOUT WAS PERFORMED. PRIMARY SURGERY WAS ON (B)(6) 2020. IT IS UNKNOWN THE OUTCOME OF THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10590440 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE REVISION DUE INFECTION. ALL THE COMPONENTS WERE REMOVED AND AN ANTIBIOTIC IMPREGNATED PROSTALAC SPACER WAS USED. THE PATIENT WAS RE IMPLANTED WITH A FULL SMITH AND NEPHEW SYSTEM ON (B)(6) 2012.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9634408 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT TWO CLOSED REDUCTIONS WERE PERFORMED ON (B)(6) 2017 AND (B)(6) 2017 ON THE RIGHT HIP REQUIRING A REVISION SURGERY ON (B)(6) 2017. NO DELAY TO PROCEDURE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 8362435 ↗
• InjuryNov 15, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE. FEMORAL HEAD AND STEM EXPLANTED AND REPLACED. DELAY OF LESS THAN 30MIN REPORTED.

  Patient problems: Injury

  MAUDE report 8075685 ↗
• InjuryMay 19, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT TRIPPED AT WORK, AND HEARD A "POP" IN HIS HIP. THE STEM BROKE AT THE NECK AS A RESULT OF THE FALL. THE STEM AND HEAD WAS REMOVED.

  Patient problems: Injury

  MAUDE report 7528393 ↗
• InjuryApr 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO INFECTION, PAIN AND SWELLING. THE SURGEON THINKS IT IS NOT THE PRODUCT FAILURE BECAUSE IT HAS TAKEN LONG TIME AFTER THE PRIMARY SURGERY. THE PRODUCTS WAS DISPOSED SO IT CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint Swelling; Unspecified Infection

  MAUDE report 7405820 ↗
• InjuryAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH RIGHT HIP DRAINAGE AND UNDERWENT AN EXCISIONAL DEBRIDEMENT, EXCHANGE OF ACETABULAR LINER, EXCHANGE OF FEMORAL BALL.

  Patient problems: Wound Dehiscence

  MAUDE report 6789966 ↗
• InjuryAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF RIGHT HIP INFECTION. THE PATIENT UNDERWENT A REMOVAL OF THE RIGHT TOTAL HIP ARTHROPLASTY AND PLACEMENT OF ANTIBIOTIC IMPREGNATED CEMENT SPACER.

  Patient problems: Deposits; Failure of Implant; Fibrosis; Toxicity; Unspecified Infection

  MAUDE report 6789965 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1901-2024 · Apr 24, 2024 · Open, Classified
  smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4