MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER NEUTRAL 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been returned to zimmer biomet for investigation.Visual examination of the returned product identified nicks, gouges, and scratches on the liner outer spherical surface, anti rotation scallop, and inner spherical surface from attempted implant.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.Report source: (b)(6).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.
Event or Problem Description
It was reported that during an initial hip procedure the liner would seat into the shell.The surgeon removed the liner and replaced with a backup liner with not complications.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information to the reported even is unavailable at this time.

• Brand Name: LINER NEUTRAL 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12860140
• Report Number: 0002648920-2021-00419
• Device Sequence Number: 19921088
• Product Code: LZO
• UDI-Device Identifier: 00889024149137
• UDI-Public: (01)00889024149137(17)260425(10)64970982
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K200823
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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 Expiration Date: 04/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 00875101036
• Device Lot Number: 64970982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• 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: 11/18/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown