MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. XLPE 0 DEG POLY LINER 56X36; PROSTHESIS, HIP

Catalog Number	00630505636
Medical Device Problem Codes	Difficult to Insert (1316); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the impactor handle broke and the surgeon decided to use what was left of the handle to complete the procedure.While impacting with the broken handle, the locking ring became dislodged and was unable to be reinserted.As a result, the liner was cemented into the shell.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03201 d10: cat#: 00626001800 / cup positioner / lot #: 63823406 cat #: 00620205620 / tm acet shell 56mm multi / lot #: 65803302 g2: chile no product was returned or pictures provided.Visual and dimensional evaluations could not be performed.The complaint was confirmed based on the returned fractured inserter.Dhr was reviewed and no discrepancies related to the reported event were found.User error was identified upon using the instrument after breakage, as per ifu (b)(4)., do not use instruments that are damaged as they may not perform as intended.User error was also identified upon insertion of the liner into the shell.Once the locking ring came out and was deformed the ring and/or shell should have been replaced.According to the ifu (b)(4)., any component should not be used if damage is found or caused during set up or insertion.Furthermore, the rim impactor or positioner cap should be used to impact the cup as per page 4 of the trabecular metal acetabular surgical technique, not a smaller test cup.Additionally, the surgical technique states on page 7 that if upon inspection it is determined the locking ring is not functioning properly or has become damaged, it must be replaced to insert the liner.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: XLPE 0 DEG POLY LINER 56X36
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18141442
• Report Number: 0002648920-2023-00274
• Device Sequence Number: 20438132
• Product Code: LPH
• UDI-Device Identifier: 00889024123816
• UDI-Public: (01)00889024123816(17)270506(10)65368997
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00630505636
• Device Lot Number: 65368997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Age: 63 YR
• Patient Sex: Male