MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 3 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 11/02/2020

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, as it has been discarded.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 any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported and one piece was scrapped with operational number 2000 and one piece scrapped with operational number 3000.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 159540.Without the opportunity to examine the complaint product and without any supporting documentation, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The event reports revision due to infection.In the risk file, infection is considered harm with a maximum severity of 4 for a number of hazards defined as critical, which is described in the severity table as: life threatening or results in permanent impairment of a body function or permanent damage to a body structure.The outcome of the reported event (revision) therefore is in line with the rmf.No corrective or preventive actions required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

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

• Brand Name: OXF ANAT BRG LT SM SIZE 3 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: 10904846
• MDR Text Key: 219541669
• Report Number: 3002806535-2020-00494
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785865
• UDI-Public: 05019279785865
• 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: 11/25/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 562700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• 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