MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT PS ANAT FM L 65MM; METAL SENSITIVE VGD PS FMRL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.Associated products: medical product: series a pat thn 34 3 peg, catalog no.: 184786, lot no.: unknown.Medical product: e1 vngd ps tib brg 71/75x10, catalog no.: ep-183640, lot no.: unknown.Medical product: tnbn pol cocr fin tib tray 71, catalog no.: 141253tnbn, lot no.: unknown.

Event Description

It was reported patient underwent left total knee arthroplasty on an unknown date in 2014.Subsequently, the patient was revised on an unknown date in 2017 due to pain.It is unknown what products were revised.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: 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.Mhr review could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 183128tnbn (initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or 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 submitted accordingly.Zimmer biomet will continue to monitor for trends.Remains implanted.

Event Description

It was reported patient underwent left total knee arthroplasty on an unknown date in 2014.Subsequently, the patient was revised on an unknown date in 2017 due to pain.It is unknown what products were revised.

• Brand Name: TINBN VG INT PS ANAT FM L 65MM
• Type of Device: METAL SENSITIVE VGD PS FMRL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12224720
• MDR Text Key: 263389279
• Report Number: 3002806535-2021-00324
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183128TNBN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/22/2021
• 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
• Patient Age: 62 YR
• Patient Weight: 66