MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 65; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994); Tissue Damage (2104); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products : item#: unknown; kne-vanguard-bearings-unk; lot#: unknown.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00424.

Event Description

It was reported that patient underwent a left revision procedure approximately 5.5 years ago for instability and periprosthetic soft tissue impingement.Patient continues to experience catching and binding.

Manufacturer Narrative

Once the investigation has been completed, an additional follow-up mdr will be submitted.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 c no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during the revision surgery.On (b)(6) 2016, the patient started experiencing periprosthetic soft tissue impingement.On (b)(6) 2016, the patient experienced pain.In a month, the patient complained about soft tissue snapping, and the current surgeon referred to another surgery as he believes the revision surgery would make it worst.On (b)(6) 2018, strong chance of posterior knee instability, possibly pcl deficiency causing ap pain, options to do nothing or possibly revise to the posterior stabilizing knee.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VANGUARD CR ILOK FEM-LT 65
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11307206
• MDR Text Key: 231139914
• Report Number: 0001825034-2021-00426
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Model Number: N/A
• Device Catalogue Number: 183028
• Device Lot Number: 866010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 06/21/2021
• Supplement Dates FDA Received: 03/04/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other