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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combined initial/ final report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical devices: medical product: oxf uni tib tray sz aa lm pma, catalog #: 159531, lot #: 822520; medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 475920.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00428, 3002806535-2020-00430.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 no similar complaints reported with the item 159531, 1 similar complaint reported with the item 159541 and 2 similar complaints reported with the item 161468.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot numbers combination.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to lateral wear.A risk assessment has not been performed for the reported event as lateral wear (disease progression) is not device related.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 Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2019.Subsequently, a revision procedure was performed on (b)(6) 2020 due to lateral wear.

• Brand Name: OXF ANAT BRG LT SM SIZE 4 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• 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: 10604738
• MDR Text Key: 209134000
• Report Number: 3002806535-2020-00429
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 464930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention