NA 1363-43-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295032755), received between Jul 26, 2017 and Jan 28, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AFTER SURGERY. DOCTOR WANTED TO REVISE AND DECIDED TO CEMENT A STEM AND REPLACE COMPONENTS. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24202759 ↗
• InjuryNov 5, 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 ARTHRITIC HIP. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Arthritis

  MAUDE report 20614987 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19477914 ↗
• 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 17002809 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16636775 ↗
• MalfunctionJan 5, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANT WAS CONTAMINATED WITH A STICKER AND ALSO LOOKS LIKE IT WAS REPACKAGED. SURGICAL DELAY OF 3 MINUTES OCCURRED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102440 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND INFECTION - CHRONIC. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT HIP). TREATMENT: IRRIGATION & DEBRIDEMENT (I & D).

  Patient problems: Unspecified Infection

  MAUDE report 13441045 ↗
• InjuryJul 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION AND FRACTURE OF PROXIMAL FEMUR. REVISION TO A TOTAL HIP. DOI: UNKNOWN; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8813349 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS DEEP INFECTION. PATIENT HAD HEMI HIP ON (B)(6) 2018. THIS WAS CASE NUMBER (B)(4) THROUGH PERFORMANCE ORTHO. SURGEON TOOK HER TO THE OPERATING ROOM AN DID AN I&D AND HEAD EXCHANGE DOI: (B)(6) 2018. DOR: (B)(6) 2018. LEFT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7893131 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD A LEFT HEMI HIP ARTHROPLASTY DONE SOMETIME IN (B)(6) 2016. THE PATIENT IS NOW COMPLAINING OF PAIN. HE WANTED TO REMOVE THE SUMMIT BASIC STEM AND MOD ENDO HEAD AND CONVERT IT TO A TOTAL HIP. HE FELT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DURING THE SURGERY HE REMOVED THE 43 MOD ENDO HEAD AND +0 SLEEVE. HE THEN USED OSTEOTOMES AROUND THE PROXIMAL PART OF STEM TO LOOSEN THE STEM. HE ATTACHED A STEM EXTRACTION DEVICE TO THE STEM AND REMOVED THE STEM FAIRLY EASY. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7641102 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6747337 ↗
• InjuryJul 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6743479 ↗

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