MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER OPTION HD 36MM; HIP PROSTHESIS

Catalog Number	650-1057
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: g7 neu +5mm arcomxl lnr 36mm g; item# 110017187; lot# 6279288.G7 pps ltd acet shell 60g; item# 010000667; lot# 6278180.Tprlc 133 t1 pps ho 18x156mm; item# 51-104180; lot# 6360476.Cer option type 1 tpr sleve +6; item# 650-1068; lot# 2953805.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 by legal that a patient had an initial left total hip arthroplasty.The patient had been doing well for 6 years but presented with sudden squeaking in the hip after an active day.X-ray and ct showed evidence of a dissociated poly insert.The patient returned to surgery 6 years and 2 months post the initial operation.During which, a pseudocapsule was debrided from the joint which revealed a dislodged poly liner and a dark stripe wear on the ceramic head.The head was removed from the taper sleeve, but the sleeve was cold welded to the femoral component and could not be removed.When the liner was removed from the cup, it was identified that the poly locking ring had sheared off the poly and was still present in the locking groove of the acetabular component.The initial stem and cup remained intact.No intra-op complications were identified.Attempts have been made and no further information has been provided at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Visual examination of the provided pictures identified the ceramic head and liner in a bag.The ceramic head appears to contain a significant amount marking visually consistent with metal transfer which indicates that the head has been in contact with metal.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: an initial left tha was performed.The patient experienced sudden squeaking in the hip after 6 years.A revision was performed, where a pseudocapsule was debrided.A dark wear stripe was noted to the ceramic head and the polyethylene ring had sheared off the poly and was still present in the locking groove of the acetabular component.The head and liner were explanted and replaced.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: BIOLOX DELTA CER OPTION HD 36MM
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22493228
• Report Number: 3002806535-2025-00265
• Device Sequence Number: 14511777
• Product Code: LZO
• UDI-Device Identifier: 00880304521957
• UDI-Public: (01)00880304521957(17)280929(10)2960379
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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 Catalogue Number: 650-1057
• Device Lot Number: 2960379
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2018
• 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