MAUDE Adverse Event Report: BIOMET UK LTD. VANG MONO FINNED STM TIB 71X12; KNEE PROSTHESIS

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Joint Swelling (2356); No Code Available (3191)

Event Date 09/02/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Medical product: vanguard cr ilok fem-lt 62.5 catalog #: 183026 lot #: 1523574, medical product: unk vanguard bearing catalog #: not reported lot #: not reported.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 experienced instability and swelling after initial left total knee surgery.

Event Description

It was reported that a patient experienced instability and swelling after initial left total knee surgery.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h4, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical review indicates that the initial surgery was performed on (b)(6) 2008 with no complications or adverse events.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.H3 other text : product not returned.

• Brand Name: VANG MONO FINNED STM TIB 71X12
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9224646
• MDR Text Key: 163946079
• Report Number: 3002806535-2019-00824
• Device Sequence Number: 1
• Product Code: JWH
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

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 Expiration Date: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 166503
• Device Lot Number: 1387873
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization