MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TIBIAL TRAY; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: the product location is currently location unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00387, 3002806535-2021-00389.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location unknown.

Event Description

It was reported, that: after surgery "left total knee arthroplasty performed on an (b)(6) 2020.Subsequently, the patient is experiencing pain, synovitis and reduced mobility.The doctor is wondering whether an undiagnosed metal allergy to a component of the cobalt chrome vanguard prosthesis could be contributing to her current situation.The patient has an appointment with an allergy specialist who has requested information and samples, if possible, of potential allergens in the implanted prosthesis to assist with the analysis (including the cement)." patient involved.

Manufacturer Narrative

This report was submitted erroneously under the incorrect mfr number.It will be recorded under mfr 0001825034-2021-03290 (biomet).Please void the initial report.

Event Description

This report was submitted erroneously under the incorrect mfr number.It will be recorded under mfr 0001825034-2021-03290 (biomet).Please void the initial report.

• Brand Name: UNKNOWN TIBIAL TRAY
• Type of Device: KNEE ARTHROPLASTY
• 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: 12505806
• MDR Text Key: 272450821
• Report Number: 3002806535-2021-00388
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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: UNKNOWN TIBIAL TRAY
• Device Lot Number: NOT COMMUNICATED
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 67 YR