MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG LG SZ5; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Combined initial / final report.Information received mentioned that no additional information available.Hence follow-up requests have not been performed.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found one complaint reported with the item(initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: appropriate rmf and most appropriate line for the reported event.Multiple hazards include a harm of non-functioning joint, which have a severity score of 3 (illness or injury that requires medical or surgical intervention) with an occurrence rate of 2 (1 in 10,000 to 1 in 100,000).The event reported that revision surgery was required.This gives a score of 3 which does not exceed the severity score on the relevant line in the risk management file.Occurrence assessment: the occurrence rate has been calculated using sales and complaint for a time period of 3 calendar years before the event date to current date, for item number 154636.Event date: (b)(6) 2021.Sales data time period: (b)(4) 2018 to (b)(4) 2021 (most up to date sales data available): (b)(4) sales data.Number of similar complaints identified: (b)(4).As the sales for this item number are low, and only one complaint has been identified, an occurrence rate can not be calculated.Therefore, no issue with the occurrence rate has been identified.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product has not been returned.
Event or Problem Description
It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2005.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2021.

• Brand Name: OXFORD UNI TIB BRG LG SZ5
• Common Device Name: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11632845
• Report Number: 3002806535-2021-00108
• Device Sequence Number: 3496785
• Product Code: NRA
• UDI-Device Identifier: 05019279388417
• UDI-Public: 05019279388417
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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 Expiration Date: 09/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 154636
• Device Lot Number: 820060
• 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: 03/23/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Weight: 48