MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC OPTION HD 28MM; HIP PROSTHESIS

Catalog Number	650-1055
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Premature Separation (4045)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure, followed by a revision surgery approximately four years later due to a dislocation.Subsequently, approximately two years and six months after the revision, the patient experienced another dislocation that required surgical intervention.During the closed reduction, the bearing and head disassociated, necessitating a second revision surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: g7 dual mobility liner 38mm c; item# 110024461; lot# 806990.28mm i.D.38mm o.D.Size c bearing; item# 110031009; lot# 65560533.Cer option type 1 tpr sleve +6; item# 650-1068; lot# 3111626.Tprlc xr mp t1 pps 13x111mm; item# 51-145130; lot# 6209866.G7 low profile screw ø6.5x15mm; item# 10000996; lot# 6263545.G7 low profile screw ø6.5x35mm; item# 10001000; lot# 6219960.G7 low profile screw ø6.5x35mm; item# 10001000; lot# 6245599.G7 osseoti multihole 48mm c; item# 110010262; lot# 6312347.G2 - foreign: japan.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 is available 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.No product was returned or pictures provided; a product evaluation 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.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.

• Brand Name: BIOLOX DELTA CERAMIC OPTION HD 28MM
• 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: 22435095
• Report Number: 3002806535-2025-00254
• Device Sequence Number: 19614771
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)320829(10)3123626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 650-1055
• Device Lot Number: 3123626
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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: Unknown