MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR INTERLOK FEM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 10/20/2012

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Concomitant medical products: vngd cr tib brg; p/n: ep-183440, l/n: 269830, vanguard cr interlok fem; p/n: 183013, l/n: 558550, polished finned tib tray; p/n: 141253, l/n: 2010101707, series a pat; p/n: 184786, l/n: 8750.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.The investigation is in process and once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11456, 0001825034 - 2018 - 11457.Remains implanted.

Event Description

It was reported a patient underwent initial knee arthroplasty six years post-implantation.Subsequently, the patient experienced stiffness and limited range of motion that was resolved post-operatively.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11456 - 1.

Event Description

No further event information available at the time of this report.

• Brand Name: VANGUARD CR INTERLOK FEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8185587
• MDR Text Key: 131377081
• Report Number: 0001825034-2018-11457
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 183013
• Device Lot Number: 558550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 89