NA 1363-08-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295032663), received between Oct 2, 2017 and Aug 27, 2026 — classified as 66 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 66 reports, in the reporter's own words as published by the FDA.

• 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 50477565 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION FOLLOWING HIP HEMI. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25202551 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION, WASHED OUT AND PUT NEW IMPLANTS IN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23453029 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP HEMIARTHROPLASTY ON (B)(6) 2025. THE PATIENT WAS VERY UNSTABLE AND CAME IN FOR A SECOND OPINION. THE SURGEON DECIDED THAT IT WOULD BE BENEFICIAL FOR THE PATIENT TO DO A CONVERSION TO A TOTAL HIP REPLACEMENT ON THE ACETABULAR SIDE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22688391 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL HEMI HIP THAT WAS CONVERTED TO A TOTAL HIP. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 22588984 ↗
• 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 21921863 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A TOTAL FOR GROIN PAIN. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21881152 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO DOCTOR WITH COMPLAINT OF HIP PAIN. THE PATIENT HAD A HEMI HIP ARTHROPLASTY DONE ON THE HIP YEARS AGO DUE TO A HIP FRACTURE. THE EXACT DATE OF IMPLANTATION IS UNKNOWN. X-RAY SHOWED A SUMMIT BASIC PRESS FIT STEM AND A UNIPOLAR HEAD. IT WAS DETERMINED BY DOCTOR THAT THE PATIENT REQUIRED REVISION SURGERY TO REMOVE THE UNIPOLAR HEAD AND SLEEVE AND CONVERT THE HEMI TO A TOTAL. IN SURGERY, THE HEAD AND SLEEVE WERE REMOVED. AT THIS TIME DOCTOR EXAMINED THE STEM AND DETERMINED IT WAS WELL FIXED. DOCTOR REAMED THE ACETABULUM TO THE APPROPRIATE SIZE AND IMPLANTED A PINNACLE CUP 1 20MM SCREW AND THE APPROPRIATE LINER. HE TRIALED FEMORAL HEADS AND DETERMINED THAT THE 32 +9 GAVE THE PATIENT THE BEST STABILITY AND RANGE OF MOTION. SO, THE 32 +9 CERAMIC HEAD WAS IMPLANTED. SALES CONSULTANT WAS ABLE TO DETERMINE THAT IT WAS A 42MM MOD CATHCART HEAD AND -3 TAPERED SPACER THAT WAS REMOVED. THERE WAS NO DELAY IN SURGERY OR ADVERSE EFFECTS TO THE PATIENT. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 20409366 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMIARTHROPLASTY DONE ON RIGHT HIP ON (B)(6) 2021. ON (B)(6), 2024 THE SURGEON REMOVED THE MODULAR CATHCART HEAD HIP BALL AND THE TAPERED SPACER DUE TO PAIN AND PUT IN A 48MM ACETABULAR CUP, LINER, AND REVISION HEAD BALL. THERE WAS NO DELAY IN THE SURGERY.

  Patient problems: Pain

  MAUDE report 20398785 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED ARTHRITIS IN HER ACETABULUM. UNKNOWN SURGICAL DELAY. DOI:(B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Arthritis

  MAUDE report 20257719 ↗
• 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: REVISON DUE TO PAIN AND OTHER. THE SLEEVE SHOWS FRETTING AND CORROSION.

  Patient problems: Pain

  MAUDE report 19840390 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR AN INFECTED HIP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19731064 ↗
• InjuryApr 26, 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 PAIN. DOI: ON (B)(6) 2019, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 19192426 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19144524 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, PERFORMED I&D AND EXCHANGED CATHCART AND SPACER. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18845912 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IT DID NOT HAPPEN IN SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18776603 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTION SO SURGEON SWAPPED THE UNIPOLAR AND SPACER AND WASHED THE PATIENT OUT. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18101704 ↗
• 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 18010397 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY DUE TO GROIN PAIN MANY YEARS AFTER A UNIPOLAR HEMIARTHROPLASTY. THE STEM WAS WELL FIXED AND LEFT IN PLACE. A PINNACLE CUP AND LINER WERE PLACED. A NEW CERAMIC HEAD WAS ADDED TO THE SUMMIT BASIC STEM. THERE WERE NO DEFICIENCIES, DELAYS OR BROKEN INSTRUMENTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17610750 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S SPACER AND UNIPOLAR SHELL REMOVED AND REPLACED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6),2023. DOR: (B)(6),2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17397538 ↗
• 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 17390043 ↗
• 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 17333778 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17002814 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16885522 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A WASHOUT AND PLACEMENT OF ANTIBIOTIC BEADS TO CURE AN INFECTION. THE SURGEON DECIDED IT BEST TO SWAP THE HEAD AND SPACER. UNKNOWN SURGICAL DELAY. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16662763 ↗

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