MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM +6 NK; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Mdr initial report: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Medical product: g7 vit e high wall lnr 36mm g, catalog #30123607, lot #64802477.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: patient arrived via the er with hip instability and reported a loud ping sound prior to reported instability while at home.X-ray showed what appeared to be a fractured biolox ceramic femoral head.Patient was taken to or later that day and the broken femoral head removed, confirmed via x-ray that all pieces were removed, and a new biolox option femoral head and new hiwall g7 liner re-implanted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the fractured head shows uneven metal transfer marks within the taper, which may have been caused by sub-optimal component alignment during assembling or after the head fractured.Numerous metal transfer marks were observed on all surfaces of the received fragments, likely from contact with the metal stem, acetabular shell and/or from contact with instruments during removal.The manufacturing history records of the biolox delta head and associated liner have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.Device is used for treatment.Medical records were not provided.The root cause of the biolox delta head fracture could not be determined in this instance without provision of surgical notes, radiographs and additional patient information.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 MOD HD 36MM +6 NK
• Common Device Name: HIP PROTHESIS
• 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: 13975116
• Report Number: 3002806535-2022-00198
• Device Sequence Number: 17337438
• Product Code: LZO
• UDI-Device Identifier: 00887868248504
• UDI-Public: (01)00887868248504(17)290401(10)2982661
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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: 12-115123
• Device Lot Number: 2982661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/19/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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 COMMENTS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male