MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Medical device site infection (4845); Periprosthetic fracture (4902)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent to hip revision surgery approximately two months post-implantation due to infection and instability.During the revision, a fracture of the greater trochanter occurred due to the amount of lysis from prior metal on metal hip replacement.
Additional Manufacturer Narrative
(b)(4).D10: cer option type 1 tpr sleve +6; item number# 650-1068; lot number# 3207905.Act artic hd arcom xl 28x38mm; item number# xl-200144; lot number# 66747541.Unknown stem; item number# unknown; lot number# unknown.Unknown shell; item number# unknown; lot number# unknown.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.
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, d2a, g3, g6, h2, h3, h6, h10, h11.The products involved in the reported event were not returned for investigation; however, pictures were provided and reviewed.The explanted products showed the presence of bio-debris; however, this observation cannot be used to confirm the reported event.As the devices were not returned, no further analysis can be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.The review identified the components were revised due to infection, instability, and prosthetic failure.We did have complications with a greater trochanteric fracture from the amount of lysis from his prior metal-on-metal hip replacement.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23013649
• Report Number: 3002806535-2025-00448
• Device Sequence Number: 9769812
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)341014(10)3216983
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 650-1055
• Device Lot Number: 3216983
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic