NA 1363-48-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295032809), received between Aug 18, 2017 and Nov 15, 2024 — classified as 23 injuries.

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

• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE SURGEON BELIEVES, THE PATIENT HAS WORN OUT HER ACETABULUM. AND THAT IS THE REASON FOR HER COMPLAINT OF HIP PAIN. REMOVED UNIPOLAR HEAD AND SLEEVE AND CONVERTED TO TOTAL HIP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 20694826 ↗
• InjuryOct 9, 2024Adverse 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. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20408165 ↗
• 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 17397767 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS FEELING UNSTABLE WITH A UNIPOLAR BECAUSE OF WEAR IN ACETABULAR CARTILAGE. THEY CONVERTED THE UNIPOLAR TO A TOTAL HIP WITH A SECTOR CUP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17351505 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIP FRACTURE AND PLACEMENT OF UNI-POLAR HEMI HIP IN 2015. SHE HAD GROIN PAIN AND RETURNED TODAY FOR REMOVAL OF HER HEMI HIP AND A THA WITH A CEMENTED SUMMIT. NO LOOSENING, BROKEN INSTRUMENTS, OR DELAYS. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15804019 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14186589 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 13825238 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MEDIAL ACETABULUM PAIN. DOI: (B)(6) 2017. DOR: (B)(6) 2021. (UNKNOWN SIDE).

  Patient problems: Pain

  MAUDE report 13250633 ↗
• InjuryJun 8, 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. THE STEM BECAME LOOSE WHEN SURGEON WAS ATTEMPTING TO REMOVE HEAD. DOI: (B)(6) 2021 - DOI: (B)(6) 2021 (LEFT HIP).

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

  MAUDE report 11957427 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE IS LEFT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10792939 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION SO THEY DID A WASHOUT AND HEAD EXCHANGE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10778340 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN FOR AN INFECTION. INFECTION WAS NOT SUPERFICIAL AND THE JOINT NEEDED TO BE WASHED OUT. THE SURGEON DECIDED TO EXCHANGE THE MOD ENDO HEAD AND SPACER. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10178377 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS CONVERTED FROM DEPUY UNIPOLAR TO STYKER DUAL MOBILITY FOR INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9819618 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEFT HIP WAS REVISED DUE TO INFECTION AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9538308 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A HEMI HIP AS TREATMENT FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019. THIS IMPLANT BECAME INFECTED AND THE PATIENT WAS BROUGHT TO SURGERY TODAY FOR REVISION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9417795 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL LEFT HEMI HIP, CONVERTED TO TOTAL HIP. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8491150 ↗
• InjurySep 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2018; UNKNOWN.

  Patient problems: Not Applicable; Pain

  MAUDE report 7872382 ↗
• InjuryJun 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. DOI: (B)(6) 2018; DOR; (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7582487 ↗
• InjuryJan 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HIP AND PAIN. DOI: UNKNOWN; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7214934 ↗
• InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. POSSIBLE INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; UNKNOWN HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7205222 ↗
• InjuryJan 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7185382 ↗
• InjuryNov 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7057942 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE SEP 12, 2017. MEDICAL RECORDS REVIEWED. IT IS INDICATED THE PATIENT RECEIVED A HEMIARTHROPLASTY OF THE RIGHT HIP DUE TO DISPLACED FEMORAL NECK FRACTURE POST FALL. APPROXIMATELY 7 WEEKS POST HEMIARTHROPLASTY THE PATIENT PRESENTED TO THE ED WITH RIGHT HIP PAIN. INFECTION WORKUP REVEALED POSITIVE STAPHYLOCOCCUS EPIDERMIS; THE FINAL IMPRESSION CONCLUDED TO BE PROSTHETIC JOINT INFECTION. IT IS ALSO INDICATED WITHIN THE MEDICAL RECORDS THAT THE PATIENT WENT ON TO RECEIVE A REVISION OF THE FEMORAL COMPONENT AND HEAD EXCHANGE WITH INCISION AND DEBRIDEMENT AND PLACEMENT OF ANTIBIOTIC BEADS. UPDATED 10-4-2017.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6803910 ↗

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