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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 lot #: 236750, medical product: oxf uni tib tray sz e lm pma catalog #: 154726 lot #: 184970.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00931, 3002806535-2019-00933.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to pain.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h4, h6, h10.D10: the product has not been returned to zimmer biomet for investigation.D11: medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 236750.Medical product: oxf uni tib tray sz e lm pma, catalog #: 154726, lot #: 184970.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00933-1, 3002806535-2019-00931-1.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 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 11 similar complaints for this item code 161469, no similar complaint for the item code 154726 and 2 similar complaints for this item code 159548.Regulatory assessment determines that the occurrence of the event and the risk remains within the acceptable limits identified in the risk management report.There were trends identified from the complaint history review.Similar hospitals can be found for several complaints.There are no trends in lot number and cause.In most cases of similar complaints, the cause could not be established.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.

Event Description

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

• Brand Name: OXF ANAT BRG LT MD SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9488453
• MDR Text Key: 174207474
• Report Number: 3002806535-2019-00930
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• 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: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 707850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2020
• 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