NA 1363-47-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295032793), received between Oct 20, 2017 and Sep 23, 2026 — classified as 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K903084); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Dislodged or Dislocated

  It was reported that the hip was dislocating over and over.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50872368 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient presented with infection near closure. Dr opted for head exchange and irrigation and debridement. Replaced head and insert. Surgery was successful.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50477459 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWED SIGNS OF INFECTION WITH A DRAINING WOUND. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24582147 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED, ALL IMPLANTS WERE EXTRACTED AND A PROSTALAC SPACER WAS IMPLANTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23997416 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. THE STEM SEPARATED FROM THE CEMENT MANTLE WHEN DISSOCIATING THE TAPER. NO HARM TO THE PATIENT WAS REPORTED. THE PROCEDURE WAS DELAYED FOR ABOUT THIRTY (30) MINUTES WHILE THE NEW CEMENT HARDENED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23716763 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HIP WAS INFECTED. DOCTOR PERFORMED AN I&D AND SWAPPED THE HEAD AND TAPER ADAPTER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23544398 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23544306 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23535704 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION AND WASHOUT. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21374650 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION AND NEEDED A NEW HEADBALL AND SPACER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21126793 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD TO REPLACE HARDWARE FROM A FRACTURED FEMUR AND NOTED AN INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20673910 ↗
• InjuryJul 26, 2024Degraded; Naturally Worn; Degraded; Naturally Worn

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO PAIN AND OTHER. THE SLEEVE SHOWS FRETTING AND CORROSION.

  Patient problems: Pain

  MAUDE report 19840139 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT WAS REVISED DUE TO INFECTION. ITEMS WERE REMOVED AND REPLACED. NO DELAY.DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18956552 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. SURGEON PERFORMED A ONE STAGE REVISION. IT WAS UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18010408 ↗
• InjuryOct 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, ATTEMPTED REDUCTION OF DISLOCATED RIGHT HIP IN ER RESULTED IN ROTATION OF ENTIRE PROSTHESIS (STEM AND UNIPOLAR HEAD) IN THE FEMORAL CANAL AND HIP JOINT. NO RESULTING FEMORAL FRACTURE. IMPLANTS WERE PULLED AND REPLACED WITH REVISION TOTAL HIP COMPONENTS. THERE WAS LOOSENING OF STEM. LOOSENING INTERFACE IS NON-CEMENTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17948346 ↗
• InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17458162 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) OF INFECTED HEMI HIP ARTHROPLASTY. THE MODULAR HEMI HEAD AND TAPER SPACER SWAPPED OUT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17390040 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEMIARTHROPLASTY HEAD AND SPACER WAS EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17333840 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I&D WITH HEAD EXCHANGE FOR INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16093768 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO RIGHT HIP PAIN FROM THE UNIPOLAR HEAD IN THE SUPERIOR ACETABULUM. THE UNIPOLAR HEAD WAS REMOVED AND THE STEM REMAINED IN SITU. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14472031 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6), 2018. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13790428 ↗
• InjuryJan 20, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS AN INFECTED HIP HEMI ARTHROPLASTY. PERFORMED INCISION AND DEBRIS WENT AND CHANGED THE UNIPOLAR HEAD AND SPACER. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13306714 ↗
• MalfunctionJun 18, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DURING OPENING, THE MATERIAL STICKER WAS ALREADY ON THE IMPLANT - THE CUSTOMER DID NOT WANT DO IMPLANT THAT. A NEW IMPLANT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025496 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON CONVERTED A HEMI TO S THA DUE TO INSTABILITY FROM THE GREATER TROCHANTER PULLING OFF THE FEMUR. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11193553 ↗
• InjuryNov 16, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT HAD HEMIARTHROPLASTY PERFORMED (B)(6) 2020. WAS BROUGHT BACK TO OR DUE TO FOREIGN BODY (CEMENT) IN ACETABULUM AND SUBLUXATION. THE FEMORAL STEM WAS NOT EXPLANTED. THE STEM WAS NOT LOOSE AND DID NOT MOVE. AFTER FOREIGN BODY REMOVED IT WAS DETERMINED THE 47MM HEAD WAS TOO LARGE AND A 46MM WAS THEN USED. TAPERED NECK (-3) WAS ALSO REPLACED. INTRA OP X-RAYS TAKEN TO CONFIRM PLACEMENT.

  Patient problems: No Code Available

  MAUDE report 10843170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K903084. One submission often covers many models, so check the product and lot details in each record.

• Z-1375-2022 · May 18, 2022 · Open, Classified
  MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 13634600