MAUDE Adverse Event Report: BIOMET UK LTD. HA TPRLOC POR LAT FML 17.5X155; HIP PROSTHESIS

Catalog Number	21-123209
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Necrosis (1971); Metal Related Pathology (4530)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 20 years post-implantation, the patient underwent a right hip revision due to metal related pathology.During the revision, corrosion material was noted around the inner bore of the femoral head.A pseudocapsule, necrotic tissue, and a cyst was debrided, which the surgeon attributed to adverse reaction to metal debris.The head was replaced.The stem and cup were retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item name: m2a 38mm mod hd std nk; item number: 11-173662; lot # 393300.Item name: m2a-38 cup 54mm; item number: rd118854; lot # 395770.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: turbid brown, dark tea-colored fluid encountered, consistent with armd.There was some but really not a significant amount of corrosion material around the inner bore of the femoral head.The trunnion on the femoral stem looked pristine without any damage.Necrotic tissue removed from around the socket, pseudocapsule excised.A definitive root cause cannot be determined.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.

• Brand Name: HA TPRLOC POR LAT FML 17.5X155
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21616632
• Report Number: 3002806535-2025-00121
• Device Sequence Number: 12890566
• Product Code: LPH
• UDI-Device Identifier: 00880304282254
• UDI-Public: (01)00880304282254(17)120930(10)909060
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K030055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 21-123209
• Device Lot Number: 909060
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2002
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male