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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mdr initial report.Product remains implanted.Concomitant medical products: item #010000938, lot #3123575, g7 hi-wall e1 liner 36mm h; item #010000669, lot #3350575, g7 pps ltd acet shell 64h; item #010000999, lot #3365486, g7 screw 6.5mm x 30mm; item #010000999, lot #3369626, g7 screw 6.5mm x 30mm; item #103207, lot #220990, taperloc por fmrl 13.5x147; item #650-1068, lot # 3123575, cer option type 1 tpr sleve +6.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 in medical notes received that patient experienced dislocation approximately 5 months post-implantation.It is unknown if medical intervention took place.
Event or Problem Description
It was reported, that: the patient experienced dislocation approximately 5 months post-implantation¿patient involvement- joint dislocation in medical notes received.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: adequate photographs have not been provided and product the has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.This device is used for treatment.A compatibility check confirms there are no issues.A review of complaint history identified 2 additional similar complaints about the reported item and no additional complaints about the written 1 other with the same item and lot combination.X-rays were not provided.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided, the product has not been returned for evaluation, and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.Corrective or preventative action is not required.The root cause of the reported event cannot be determined with the information provided.A supplemental report will be tendered accordingly if any additional information is discovered or received that may adjust any conclusions or data.Zimmer biomet will continue to monitor for trends.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• 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: 14369242
• Report Number: 3002806535-2022-00240
• Device Sequence Number: 20279412
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: 00887868271397
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: Health Professional
• Device Expiration Date: 03/19/2025
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 592710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2015
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male