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

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision approximately four (4) years after initial left total hip arthroplasty.During the revision some metallosis was noted within the soft tissues, acetabular liner was fragmented, the head had significant metal like wear, and one screw was prominent of 0.5mm within the acetabulum.The head, liner, taper, and ringloc were replaced and the prominent screw was removed.The joint was irrigated without debridement and the surgery was completed without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: associated products: item reference: ep-105790, item name: epoly 36mm +5 rglc lnr hw sz23, item lot:315070.Item reference: 103533, item name: ti low profile screw 6.5x30mm, item lot:590690.Item reference: 650-1066, item name: cer opt type 1 tpr sleve 0mm, item lot:2946658.Item reference: pt-116054, item name: regen/rnglc+ ltd 54mm sz 23, item lot:497840.Item reference: 103533, item name: ti low profile screw 6.5x30mm, item lot:590690.Item reference: 51-103090, item name: tprlc 133 type1 pps so 9x137mm, item lot:6137664.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, d2, d4, d9, g1, g3, g6, h1, h2, h3, h6, h10 visual examination of the provided pictures identified discoloration on the ceramic head was likely caused by metal transfer due to contact between the head and the metal shell after liner fracture.No obvious damage or failure could be identified to the sleeve from the photograph provided.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were not provided.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 available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• 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: 17215615
• Report Number: 3002806535-2023-00212
• Device Sequence Number: 3023499
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: (01)00887868271397(17)280829(10)2948089
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 2948089
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female