MAUDE Adverse Event Report: BIOMET UK LTD. CER OPT TYPE 1 TPR SLEVE 0MM; CER BIOLOXD OPT TYPE 1 TPR SLV

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Associated products: medical product: e-poly 32mm +3 maxrom lnr sz22, catalog number: ep-108222, lot number: 198270.Medical product: ringloc+ replacement ring sz22, catalog number: 106022, lot number: 295710.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00008.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not to be returned to zb.
Event or Problem Description
It was reported, that: a patient underwent an initial right hip arthroplasty on an unknown date.Patient total hip was fine.Subsequently, patient experienced acute onset of pain and squeaking.Pain became severe over a week or so, had to go to crutches.Patient involvement- revision surgery.
Event or Problem Description
It was reported, that: a patient underwent an initial right hip arthroplasty on an unknown date.Patient total hip was fine.Subsequently, patient experienced acute onset of pain and squeaking.Pain became severe over a week or so, had to go to crutches.Patient involvement- revision surgery.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: visual examination of the one provided photograph identified the ceramic head to have scuffing all around the outside diameter.Adequate photographs have not been provided and the product 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.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.These devices are used for treatment.The implants reported in this event are compatible.Review of complaint history identified no additional similar complaints for the reported item 650-1056 and no additional complaints for the reported item and lot combination / additional no similar complaints for the reported item 650-1066 and item and lot combination.Medical records or x-rays have not been provided.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and 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 reported event.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2022-00008-1.

• Brand Name: CER OPT TYPE 1 TPR SLEVE 0MM
• Common Device Name: CER BIOLOXD OPT TYPE 1 TPR SLV
• 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: 13257615
• Report Number: 3002806535-2022-00009
• Device Sequence Number: 4740537
• Product Code: LZO
• UDI-Device Identifier: 00887868271489
• UDI-Public: 00887868271489
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1066
• Device Lot Number: 3053198
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG