NA 71336530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010197672), received between Nov 27, 2018 and Nov 4, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K920430); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE UNIV CAN ACET SCREW 30MM DEVICE WAS FOUND TO BE DELAMINATED AT THE END OF ITS INSERTION IN THE ACETABULAR CUP, IT WAS REMOVED AND ANOTHER S+N BACK-UP SCREW OF THE SAME SIZE WAS PLACED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727185 ↗
• MalfunctionJul 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE HEAD OF AN UNIV CAN ACET SCREW 30MM FRACTURED AFTER PLACING THE SCREW IN ONE OF THE HOLES AND DRILLING WITH THE DRILL BIT. SURGERY WAS FINISHED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE, THE SCREW WAS IMPACTED TO FIX IT AND TO BE ABLE TO PLACE THE INSERT. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136946 ↗
• InjuryJun 23, 2020Difficult to Insert; Misconnection; Difficult to Insert; Misconnection

  IT WAS REPORTED THAT AFTER SURGERY THE ACETABULAR SCREW EXITED THE SCREW HOLE IN THE 52MM R3 MULITHOLE CUP, THIS WAS SEEN IN AN X-RAY. THE SURGEON REPORTED THE SCREW WAS FIRMLY SEATED AT THE BOTTOM OF THE HOLE WITH EXCELLENT PURCHASE. IT APPEARED TO GO BEYOND THE CUP AT THE TIME IT WAS IMPLANTED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10183178 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN (B)(6) HOSPITAL, A SURGEON PERFORMED A HIP REPLACEMENT SURGERY. THE 48MM R3 ACETABULUM CUP WAS IN AN APPROPRIATE LOCATION ACCORDING TO FLUOROSCOPY. THEN THREE SCREWS WERE IMPLANTED, AND IMPLANTED 48MM CERAMIC INSERT. AFTER LOAD TEST, A SCREW WAS FOUND THROUGH THE OUTER CUP PROSTHESIS SCREW HOLE DIRECTLY INTO THE PELVIS. SUBSEQUENTLY THE SURGEON HAD A ACETABULUM SIDE REVISION SURGERY, REMOVED SIDE PROSTHESIS, FOUND THE SCREW HOLE DEFORMATION OF ACETABULUM PROSTHESIS. THEN FILE TO 54, OUTER CUP TRIAL IMPLANTED, IT WAS STABLE. AFTER THAT, 54 ACETABULUM PROSTHESIS AND CERAMIC INSERT WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 8107895 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K920430. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.