MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XLPE 10DEG POLY LINER505254X32; PROSTHESIS, HIP

Catalog Number	00-6310-050-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately two years later due to a psoas conflict.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: italy.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.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 {update/corrected}.Updated: d4; d6b; g3; h2; h3; h4; h6; h10.D6a - implant date - unknown month and day in 2023.Visual examination of the provided pictures identified explanted devices with signs of use (scratches, gouges, dried debris).Devices not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and identified the following: left total hip arthroplasty without acute hardware complication.Iliopsoas impingement is often due to excessive anterior overhang of the acetabular cup from oversize components or improper cup version, which cannot be assessed from the provided ap view-a crosstable lateral view or ct would be necessary to make this assessment and ultrasound can visualize the tendon directly as well as any dynamic impingement or bursitis.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.
Event or Problem Description
No further information at the time of this report.

• Brand Name: XLPE 10DEG POLY LINER505254X32
• 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: 22369906
• Report Number: 0001822565-2025-02244
• Device Sequence Number: 11916502
• Product Code: LPH
• UDI-Device Identifier: 00889024124721
• UDI-Public: (01)00889024124721(17)2903025(10)66579784
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00-6310-050-32
• Device Lot Number: 66579784
• Was Device Available for Evaluation?: No
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown