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

Catalog Number	30123206
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the liner was unable to be inserted into the cup.The surgeon suggested possible poor bone quality or angulation.The procedure was completed using another device.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 30123206, item name: 32mm i.D.Size f high wall liner , lot # 65257133.30123606 , item name: 36mm i.D.Size f high wall liner, lot # 65257326 110010245, item name: g7 osseoti 4 hole shell 54mm f, lot # 65698321.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 information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h11 visual examination of the returned product, all 3 liners have deformations to the outside rim lock, scratches/gouges to outside spherical surface, gouges to outside tapered surface, and gouges to the top rim surface.It also has deformations and burrs on anti-rotation scallops.No other damage was noted during visual evaluation.All 3 liners measured in specification.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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
There is no update to the prior event description provided.

• Brand Name: 32MM I.D. SIZE F HIGH WALL LINER
• Common Device Name: PROSTHESIS, HIP
• 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: 21313528
• Report Number: 0001822565-2025-00270
• Device Sequence Number: 8151110
• Product Code: LPH
• UDI-Device Identifier: 00889024520448
• UDI-Public: (01)00889024520448(17)290818(10)66855164
• 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): 05/16/2025

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 Catalogue Number: 30123206
• Device Lot Number: 66855164
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: PLEASE SEE H11.
• Patient Sex: Unknown