MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 4 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: associated products only.Associated item number 154722, lot 602720, item name: oxf uni tib tray sz c lm pma.Associated item number 402283, lot 308380, item name: cobalt g-hv bone cement 40g.Associated item number 161469, lot unknown, item name: oxf twin-peg cmntd fem md pma.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent an initial left unilateral tka on (b)(6) 2015.The patient was revised on (b)(6) 2019 due to pain and poly instability.The polyethylene bearing was upsized.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.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.Mhr review could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 2 similar complaints reported with the item 159548.Trends were identified from complaint history review.2 complaints were reported in same hospital.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports legal allegations of pain and instability.Risk management report documents the estimated residual risk associated with the reported event.The root cause of this complaint could not be determined with the information provided to date.Therefore, a line relating to a specific hazard could not be selected for assessment.The reported event states allegations of pain.Pain is considered a harm for multiple lines in the risk file with a severity score of 3: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The reported event also states allegations of instability.Instability is considered a harm for multiple lines in the risk file with a severity score not exceeding 3: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf 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.
Event or Problem Description
It was reported by patients legal counsel that the patient underwent an initial left unilateral tka on (b)(6) 2015.The patient was revised on (b)(6) 2019 due to pain and poly instability.The polyethylene bearing was upsized.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

• Brand Name: OXF ANAT BRG LT MD SIZE 4 PMA
• Common Device Name: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11054865
• Report Number: 3002806535-2020-00553
• Device Sequence Number: 2699872
• Product Code: NRA
• UDI-Device Identifier: 05019279785940
• UDI-Public: 05019279785940
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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