NA 1363-53-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295032854), received between Nov 17, 2017 and Apr 1, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24758633 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21921874 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D HEAD EXCHANGE WAS PERFORMED. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19664901 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS HIP WAS INFECTED, IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED WITH HEAD AND SPACER EXCHANGE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18687007 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN FROM A HEMIARTHROPLASTY TO A COMPETITIVE DUAL MOBILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17172207 ↗
• InjurySep 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED DUE TO DISLOCATION. PATIENT HAS MENTAL ISSUES THAT COULD HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15417308 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14628487 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED HEMI HIP. HIP WAS WASHOUT AND HEAD WAS EXCHANGED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12960547 ↗
• InjuryNov 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A HEMI-ARTHROPLASTY AND DISLOCATED. THE SURGEON ELECTED TO REMOVE THE HEAD AND PUT IN A MOM CUP FROM A COMPETITOR COMPANY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10830721 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS INFECTED HIP HEMIARTHROPLASTY. INCISION AND DEBRIDEMENT AND HEAD/SPACER EXCHANGE. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10509780 ↗
• InjuryAug 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT CAME TO ER DISLOCATED. SURGEON EXPLANTED CURRENT 53 UNIPOLAR HEAD BALL AND +5 TAPERED SLEEVE AND BEGAN TRIALING WITH + 5 28 MM AND 53 BIPOLAR HEAD BALL WITHOUT LUCK OF STABILITY. HE THEN TRIALED WITH +8.5 28MM HEAD BALL AND STILL WAS DISSATISFIED WITH STABILITY. HE DECIDED TO EXPLANT SUMMIT STEM (8STD) AND IMPLANT 8 HI SUMMIT STEM WITH + 5 28MM HEAD BALL WITH A DUAL MOBILITY COMPETITOR MDM CUP. SURGEON STATED HE WAS DISPLEASED WITH DEPUY¿S ABILITY TO PROVIDE A DUAL MOBILITY PINNACLE IMPLANT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10362425 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNIPOLAR HIP GROIN PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10344541 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GROSSLY INFECTED. ALL IMPLANTS WERE REMOVED. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS FROM COMPETITOR'S. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8730552 ↗
• InjuryMay 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. THE SURGEON CHANGED STEM FROM KA16 TO KLA16 WITH A 53 BIPOLAR 28+15.5 HEAD. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8631656 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS ALSO REMOVAL OF IMPLANTS, WASH OUT AND RE-IMPLANTATION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8604797 ↗
• InjuryJan 31, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. SURGEON PERFORMED CLOSED REDUCTION RECENTLY AND WITHIN 3 WEEKS DISLOCATED AGAIN. IMPLANTED CUP WITH CONSTRAINING LINER AND LEFT THE ORIGINAL HIP STEM TO CONVERT TO A TOTAL. (B)(6) 2017; (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7230315 ↗
• MalfunctionNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO PLACE SMALLER ENDS HEAD ON STEM. IT WAS INDICATED THAT THE HEAD IMPLANT WAS TOO LARGE AND NEVER FULLY REDUCED.

  Patient problems: No Information

  MAUDE report 7040480 ↗

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