MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has been experiencing right hip issues and pain since his initial implantation.It is now approximately 11 (eleven) years post-surgery.The patient reports the surgeon is concerned for trunnionosis and metallosis.An mri is scheduled to be completed in two weeks, and laboratory work is being completed for metal pathology.No further details or medical records have been provided.
Additional Manufacturer Narrative
(b)(4).Previously report submitted under warsaw biomet mfr number 0001825034.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, g3, g6, h2, h10, h11.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
It was reported that the patient has been experiencing right hip issues and pain since his initial implantation.It is now approximately 11 (eleven) years post-surgery.The patient reports the surgeon is concerned for trunnionosis and metallosis.An mri was performed that displayed small chronic bone fragments at the greater trochanter; otherwise, unremarkable without evidence of osseous abnormality or osteolysis.All products remain implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: item name# cer option type 1 tpr sleve -6; item number# 650-1064; lot number# 992340.Item name# g7 pps ltd acet shell 52e; item number# 010000663; lot number# 3360499.Item name# e1 std poly liner e36; item number# 010000857; lot number# 3302871.Item name# tprlc 133 mp type1 pps so 11.0; item number# 51-106110; lot number# 3311802.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, d10, g3, g6, h2, h3, h4, 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 related to the reported event.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 and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a right tha on (b)(6) 2014.Patient has since been having issues and reporting pain in the hip.During the follow-ups the doctor notes he is concerned for metallosis and trunnionosis.Patient had x-rays and blood lab results.Results have no evidence of fracture or dislocation, had good alignment.Lab test results for chromium and cobalt are normal within range.Mri results show no evidence of osseous abnormality or osteolysis.Mild right gluteus medius and minimus tendinosis with low grade insertion fraying.Advanced degenerative changes of lower lumbar spine.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: CER BIOLOXD OPTION HD 36MM
• 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: 23726010
• Report Number: 3002806535-2025-00563
• Device Sequence Number: 10642090
• Product Code: LZO
• UDI-Device Identifier: 00887868248580
• UDI-Public: (01)00887868248580(17)240825(10)392850
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 02/27/2026

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 Expiration Date: 08/25/2024
• Device Catalogue Number: 650-1057
• Device Lot Number: 392850
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 02/27/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2014
• 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 H11; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG