NA 1363-44-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295032762), received between Jul 21, 2017 and Jun 24, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY TO HAVE THE HEMI ARTHROPLASTY CONVERTED TO TOTAL HIP DUE TO DEGENERATIVE ACETABULAR CHANGES AND ONSET OF PAIN. THE STEM WAS LEFT IN PLACE AND THE LEFT ACETABULAR IMPLANT WAS PLACED. NO ISSUES OR CONCERNS REPORTED WITH THE IMPLANTS. AFFECTED SIDE-LEFT.

  Patient problems: Pain

  MAUDE report 25611094 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEMI REVISED TO TOTAL DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 25073259 ↗
• 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 22588910 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AND DISCOMFORT, SO DOCTOR REMOVED UNIPOLAR HEAD BALL AND CONVERTED HEMI TO A TOTAL KEEPING ORIGINAL SUMMIT STEM, BUT REPLACED CUP AND LINER WITH ANOTHER VENDORS SYSTEM. NO INFECTION PRESENT, NO DELAY IN SURGERY. DOI: (B)(3) 2019. DOR: (B)(3) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Pain

  MAUDE report 18367390 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 16246564 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR HIP PAIN. THERE WAS NO SURGICAL DELAY. DOI - (B)(6) 2022. DOR - (B)(6) 2022. AFFECTED SIDE - LEFT HIP.

  Patient problems: Pain

  MAUDE report 16156577 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT , I & D PERFORMED DUE TO INFECTION. HEAD WAS SWAPPED OUT FOR THE SAME SIZE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16132767 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED FOR HIP PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16114341 ↗
• InjuryFeb 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC OF THEIR COMPETITOR HEMI HIP PROSTHESIS. THE SURGEON REMOVED THE INDWELLING HIP AND REPLACED IT WITH A 10¿ BOWED SOLUTION STEM AND A NEW HEMI HEAD/TAPER SPACER ON (B)(6) 2022. A FEW DAYS AFTER THIS SURGERY, THE PATIENT'S HIP DISLOCATED. THE SURGEON DETERMINED THAT THE STEM ROTATED AND NEEDED TO BE REPLACE WITH A LARGER DIAMETER STEM. THIS NEW PROCEDURE HAPPENED ON (B)(6) 2022. THE STEM, HEAD AND TAPER SPACER WERE ALL REPLACED. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13542344 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CONVERSION OF HEMI TO TOTAL DUE TO HIP PAIN. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 13250576 ↗
• InjurySep 22, 2021Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. PATIENT HAD AN ALVAL ON THE SIDE OF HER HIP LEADING THE SURGEON TO BELIEVE THAT THE HIP PROSTHESIS WAS HAVING MICROMOTION CAUSING SOME METAL WEAR. ORIGINALLY IMPLANTS WERE A COBALT CHROME SUMMIT CEMENTED STEM WITH A COBALT CHROME SPACER AND MONOPOLAR HEMI ARTHROPLASTY HEAD. SHE WAS REVISED TO A TOTAL HIP WITH A PINNACLE CUP, ALTRX LINER, SCREW, CORAIL REVISION, AND DELTA CERAMIC HEAD. LACK OF METALOSYS IN JOINT BUT RAISED ION LEVELS PRE OP. DOI: (B)(6) 2018. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction

  MAUDE report 12513509 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED A WASHOUT DUE TO INFECTION. BOTH HEAD AND SPACER WERE REMOVED, THE ACETABULUM WAS CLEANED AND A REPLACEMENT HEAD AND SPACER WAS IMPLANTED. DOI: (B)(6) 2012. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11844156 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTION A COUPLE WEEKS OUT FROM HER PRIMARY SURGERY. THE SURGEON WASHED OUT THE HIP, ADDED ANTIBIOTIC BEADS AND DECIDED TO SWAP OUT THE HEAD/TAPER. THE SAME HEAD AND TAPER WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

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

  MAUDE report 11322694 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAINFUL HIP. DO NOT KNOW WHEN PRIMARY SURGERY WAS PERFORMED. COULD NOT READ ANY NUMBERS ON THE MOD CATHCART SPACER BUT IT WAS A 44 HEAD. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10754769 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. THERE WERE NO ALLEGATION. DOI: (B)(6) 2005; DOR: NONE REPORTED LEFT HIP.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9720873 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, HEMI HIP WAS CONVERTED TO A TOTAL HIP. DOI: (B)(6) 2019. DOR: (B)(6) 2019, (LEFT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 9574757 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN FOLLOWING UNIPOLAR HIP. DOI: (B)(6) 2017, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8811955 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION, SURGEON PREFORMED A I&D AND EXCHANGED HEAD AND TAPER. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8811181 ↗
• InjuryMay 28, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT¿S HEMIARTHROPLASTY WAS MIGRATING SUPERIOR IN THE SOCKET AND NEEDED REVISION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8645663 ↗
• InjuryMay 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8632175 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP GOT INFECTED. ALL COMPONENTS WERE REMOVED. THE WOUND WAS THOROUGHLY IRRIGATED AND NEW IMPLANTS WERE PLACED IN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8625362 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXCHANGE OF HEAD AND SLEEVE FOR IRRIGATION AND DEBRIDEMENT. PATIENT WAS ALSO INFECTED. LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8323481 ↗
• InjuryNov 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS ACETABULAR PAIN.

  Patient problems: Pain

  MAUDE report 8034361 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7946467 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE AUG 14, 2017: ADDITIONAL INFORMATION RECEIVED. THE SUMMIT BASIC STEM LOOSE. LOOSENING OCCURRED FROM BONE TO IMPLANT INTERFACE. THIS COMPLAINT WAS UPDATED ON AUG 15, 2017.

  Patient problems: Pain

  MAUDE report 6731268 ↗

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