MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 44MM O.D. SIZE EE POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH EE LINERS; PROSTHESIS, HIP

Catalog Number	00875304401
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the liner wouldn't fit inside the cup.In the process of inserting, the acetabular wall was fractured.As a result, the patient will need to undergo another procedure to correct the adverse event.No further intervention has been reported to date.There is no further information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00875200628, item name: hxpe liner elevated ee28, lot # 66817052.00-6250-065-15, item name: trilogy bone scr 6.5x15, lot # j7733806.00-6250-065-25, item name: trilogy bone scr 6.5x25, lot # j7758932.00-6250-065-20, item name: trilogy bone scr 6.5x20, lot # j7680223.G2: foreign: india.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.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified the shell has scratches and nicks are present all around the internal surfaces and top flat rim of the shell.Outside diameter of rim has scratches as well.No other damage was noted during visual evaluation.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.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: 44MM O.D. SIZE EE POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH EE LINERS
• 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: 21976118
• Report Number: 0001822565-2025-01275
• Device Sequence Number: 12579110
• Product Code: JDI
• UDI-Device Identifier: 00889024150096
• UDI-Public: (01)00889024150096(17)330805(10)66137592
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200823
• 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): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00875304401
• Device Lot Number: 66137592
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female