MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STANDARD LINER 32 MM I.D.; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number	00610505032
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the liner would not seat in the trilogy cup.No patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Foreign - event occurred in canada.Visual examination of the returned product identified damage is observed to bottom of liner on boss.Damage is observed on bottom of rim and the top.Noticed positive material on cut-outs where the liner mates with shell.It is unknown it the damage occurred during implantation or prior.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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: STANDARD LINER 32 MM I.D.
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 15293215
• Report Number: 0002648920-2022-00179
• Device Sequence Number: 2292222
• Product Code: LPH
• UDI-Device Identifier: 00889024359758
• UDI-Public: (01)00889024359758(17)270831(10)64493916
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934765
• 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): 08/23/2022

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: 00610505032
• Device Lot Number: 64493916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• 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: 08/23/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2019
• 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: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose