inforMED
MalfunctionJDI

UNKNOWN CUP

Received Jul 1, 2026 · Event occurred Jun 8, 2026

Report 0001822565-2026-02394 · MDR key 25677867

Device

Generic name

Prosthesis, Hip

Catalog number

UNKNOWN CUP

Lot number

UNKNOWN

Product problems

  • Degraded
  • Separation Failure

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER INDICATED THAT THE PRODUCT WAS DISCARDED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE REMOVING THE MANHOLE COVER SCREWS, ONE OF THE SCREWS WAS LOCKED AND COULD NOT BE REMOVED. AFTER MULTIPLE ATTEMPTS TO REMOVE IT, THE SCREW CAP BECAME STRIPPED AND COULD NOT BE REMOVED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.