MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE F HIGH WALL LINER; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the liner could not be inserted.The surgeon used another product of the same size to complete the surgery.There was a three (3) minute delay in surgery due to the product change.The initial cup was implanted into the patient.There was no impact or harm to the patient.
Additional Manufacturer Narrative
(b)(4).D10: 110010245 g7 osseoti 4 hole shell 54mm f 66526562; g2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified the liner has gouges to the elevation angled surfaces on both sides.Outside scallops have gouges, multiple is deformed on the bottom side.Outside tapered surface has scratches and gouges.Outside rim lock surface has burr like positive material with a portion of it hanging off.No other damage was noted during visual evaluation.Device measured within specification.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.This complaint can be confirmed via the returned product evaluation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: 32MM I.D. SIZE F HIGH WALL LINER
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21645239
• Report Number: 0001822565-2025-00673
• Device Sequence Number: 7713527
• Product Code: LPH
• UDI-Device Identifier: 00889024520448
• UDI-Public: (01)00889024520448(17)290805(10)66829146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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 Model Number: N/A
• Device Catalogue Number: 30123206
• Device Lot Number: 66829146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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 H11 NARRATIVE.
• Patient Sex: Unknown