NA 1363-49-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295032816), received between Oct 12, 2017 and Jan 20, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS UNIPOLAR BECAME PAINFUL AND WANTED A TOTAL HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24116925 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23423679 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI HIP DONE PRIOR WITH A SUMMIT CEMENTED STEM AND FRACTURE HEADBALL WITH TAPERED SPACER. THEY DEVELOPED ARTHRITIS AND NEEDED A REVISION OF THE ACETABULUM. HEAD AND SPACER WERE REMOVED BUT THE STEM STAYED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Arthritis

  MAUDE report 20269174 ↗
• 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. T DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19731124 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD HEMI HIP AND SHE WAS CONVERTED TO A TOTAL. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18920344 ↗
• InjuryFeb 22, 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 18763356 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNIPOLAR SUMMIT CEMENTED HEMI HIP CONSTRUCT FOR A HIP FRACTURE IN LATE AUGUST. UNFORTUNATELY, SHE IS CONFIRMED FOR INFECTION. THE MOD ENDO HEAD AND SPACER WERE REMOVED. THE HIP WAS WASHED OUT AGGRESSIVELY AND A NEW MOD ENDO HEAD AND SPACER WAS UTILIZED. SURGICAL DELAY UNKNOWN. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17998811 ↗
• 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 17610770 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR REMOVAL OF HEMI HIP DUE TO INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16296582 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13343379 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12337702 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIP PAIN. THE UNIPOLAR SIZE 49 AND +0 SPACER WERE REMOVED AND TOTAL HIP WAS DONE TO RELIEVE THIS ISSUE. DOI: (B)(6) 2016. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10471519 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTED HIP. DOI: (B)(6) 2020. DOR: (B)(6) 2020, AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10097652 ↗
• InjuryMay 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A FALL AFTER A HEMI HIP AND DISLOCATED. SHE CONTINUED TO DISLOCATE MULTIPLE TIMES FOLLOWING THAT FIRST FALL. THE SURGEON CONVERTED THIS PATIENT TO A TOTAL HIP LEAVING THE WELL FIXED STEM IN PLACE. DOI: (B)(6) 2020; RIGHT HIP.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10025638 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE HIP. CONVERTED FROM A HEMI HIP TO A TOTAL HIP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SITE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9868311 ↗
• InjuryFeb 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HIP DISLOCATED AND COULD NOT BE REDUCED, SO THE PATIENT WAS OPENED AND THE SURGEON PULLED THE STEM OUT WITH LITTLE EFFORT. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9711178 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2019 (UNKNOWN HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 9586828 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8941516 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8169901 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8048076 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS STATED THAT PATIENT ORIGINALLY HAD HEMI HIP AND CONVERTED TO TOTAL HIP. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7471862 ↗
• InjuryFeb 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I AND D WAS DONE. HEAD AND SPACER REPLACED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7233600 ↗
• InjuryOct 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6944014 ↗

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