MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER OPTION TYPE 1 TPR SLEVE -3; HIP PROSTHESIS

Catalog Number	650-1065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: cer bioloxd option hd 28mm; item# 650-1055; lot# 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.
Event or Problem Description
It was reported that approximately nine years and six months post implantation, the patient was revised for leg length discrepancy.It was indicated that the patient required longer head length.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information the following sections were updated: b4, b5, g3, g6, h1, h2, h6, h11.Visual examination of the pictures identified a ceramic head, taper adaptor and dual mobility liner.The parts were returned assembled.There is what appears to be metal transfer to the ceramic head and damage to the taper adaptor, likely caused during the revision surgery when removing from the stem taper.Nothing can be gained from the photo regarding the reported event of leg length discrepancy.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history found no additional related complaints for these items.Radiographs were provided assessed images for left hip.Images were not submitted to a radiologist as they do not provide full bilateral leg length images to fully assess the discrepancy.With the available information, 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 CER OPTION TYPE 1 TPR SLEVE -3
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19257901
• Report Number: 3002806535-2024-00161
• Device Sequence Number: 2581823
• Product Code: LZO
• UDI-Device Identifier: 00887868271472
• UDI-Public: (01)00887868271472
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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: 650-1065
• Device Lot Number: UNKNOWN
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Sex: Female