NA 1363-42-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295032748), received between Aug 31, 2017 and Aug 27, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse 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. ORIGINAL IMPLANT DATE WAS (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 22906977 ↗
• InjuryApr 21, 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 21873962 ↗
• InjuryApr 1, 2025Adverse 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. IRRIGATION AND DEBRIDEMENT NEEDED WITH A HEAD/SPACER SWAP. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 21739972 ↗
• 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 20409078 ↗
• 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 19192425 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED, ALL IMPLANTS DEEMED APPROPRIATE SIZE PLACEMENT, UNIPOLAR HEAD AND SPACER REPLACED IRRIGATION AND DEBRIDEMENT (I&D) PROCEDURE. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 18685766 ↗
• InjuryMay 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED 3 TIMES, DATES PRIOR TO DAY ARE UNKNOWN. PATIENT BROUGHT TO OR AND RELOCATED AND FOUND TO BE VERY STABLE. HOWEVER AFTER MULTIPLE DISLOCATIONS, SURGEON CHOSE TO CONSTRAIN. NO PATIENT HARM OCCURRED. STEM LEFT IN PLACE AND A CUP SCREWS AND CONSTRAINED LINER WERE PLACED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16854468 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16294517 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. PATIENT WAS REVISED FROM A HEMI HIP TO A TOTAL HIP. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15040739 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI DONE IN (B)(6) 2021, PATIENT IS INFECTED. REMOVED IMPLANTS AND CEMENTED IN ANOTHER HEMI WITH ANTIBIOTIC IMPREGNATED CEMENT. I HAVE NO OTHER INFORMATION. THERE IS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14307281 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2021; (LEFT HIP).

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

  MAUDE report 12384157 ↗
• InjuryNov 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED HIP DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9362866 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION HIP: DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR: INFECTION - STAPH. PATIENT PRESENTED TO THEATRE OVER THE WEEKEND OF 14/15 OF JULY WITH INFECTED HIP. THIS WAS WASHED OUT AND A VAC/IRRIGATION DRESSING APPLIED. WAS TAKEN BACK TO OT ON TUESDAY (B)(6) FOR ATTEMPTED REVISION FOR REMOVAL OF HEAD AND REPLACE WITH POSSIBLE CEMENT IN CEMENT REVISION OF STEM. AT THIS TIME ONLY A WASHOUT OCCURRED AGAIN AND VAC DRESSING - (B)(4). JNJ REPRESENTATIVE ON CHECKING THE UPCOMING REVISION DATE WAS TOLD THIS HAD OCCURRED LAST NIGHT ((B)(6) 2018) WITHOUT REP PRESENT. FEMALE PATIENT ID: (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 7780899 ↗
• InjuryJul 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO REPORTED THAT THE SURGEON ELECTED TO CONVERT THE HEMI TO A TOTAL HIP ARTHROPLASTY. THE UNI POLAR COMPONENTS WERE EXPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7669321 ↗
• InjuryFeb 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Joint Dislocation

  MAUDE report 7285480 ↗
• InjuryAug 31, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THAT A PATIENT HAD A HEMI HIP ARTHROPLASTY DONE ON (B)(6) 2017. SURGEON CALLED AND SAID THAT THE PATIENT HAD DISLOCATION. HE WANTED TO LENGTHEN THE SLEEVE AND CHANGED THE HEAD. HE ENDED UP CHANGING FROM A -3 SLEEVE TO A +10 SLEEVE. THE PATIENT SEEMED TO BE MORE STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 6835758 ↗

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