MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER MOD HD 28MM +3 NK; HIP PROSTHESIS

Catalog Number	12-115111
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: echo por fmrl nc 11x135mm; item# 192011; lot# 441380.Bone screw self-tapping 6.5 mm dia.30 mm length; item# 00625006530; lot# 64378436.Bone screw self-tapping 6.5 mm dia.35 mm length; item# 00625006535; lot# 64383906.Bone screw self-tapping 6.5 mm dia.40 mm length; item# 00625006540; lot# 64172354.G7 osseoti multihole 60mm g; item# 110010268; lot# 6463667.G7 dual mobility liner 46mm g; item# 110024465; lot# 665360.It is unknown if the device will be returned to zimmer biomet 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 approximately 5 years and 6 months post-implantation, the patient indicated that they will be undergoing a planned hip revision surgery.Reason for the revision is currently unknown.It is also unknown if the revision has taken place.Due diligence is in progress for this complaint; no further additional information or product has been received at the time of this report.
Event or Problem Description
It was reported that approximately 5 years and 6 months post-implantation, the patient underwent a revision surgery due to mechanical failure of the dual mobility bearing with dislocation.The liner and head were replaced.Attempts have been made; however, no further event details or products have 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: b1, b2, b3, b4, b5, d6, e1, e2.E3, g3, g6, h2, h6, h11.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.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.With the available information, 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 MOD HD 28MM +3 NK
• 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: 21737383
• Report Number: 3002806535-2025-00139
• Device Sequence Number: 17139062
• Product Code: LZO
• UDI-Device Identifier: 00887868248429
• UDI-Public: (01)00887868248429(17)281122(10)2965002
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051411
• 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: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2025

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: 12-115111
• Device Lot Number: 2965002
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 06/27/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/28/2025; 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Male