MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 3 PMA; KNEE PROTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Product not returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure was performed due to infection.

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.In addition, 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 unit piece scrapped with operational number 0020.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 159575.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in cause.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: the event reports revision due to infection.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.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 this complaint is considered to be within the severity of the rmr.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure was performed due to infection.

• Brand Name: OXF ANAT BRG RT MD SIZE 3 PMA
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9937552
• MDR Text Key: 187038683
• Report Number: 3002806535-2020-00228
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 116320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention