MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 60; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: 2012.Concomitant medical devices: therapy date: unknown; unknown tibial component; unknown bearing.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00301, 0001822565-2021-00302.

Event Description

It was reported that patient underwent right total knee arthroplasty approximately 11 years ago.Subsequently, patient is experiencing pain and stiffness.The patient states that if she climbs the stairs more than a couple of times a day, she experience a lot of pain.She now lives downstairs and tries not to use the stairs.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

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.No devices were received; therefore the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-ray report provided by surgeon states that the prosthesis is in good alignment and patient has no fracture with presence of mild swelling noted.Additionally, in the findings there is a note of chronic appearing avoid ossicles superior and inferior to the patella and posterior to the joint line along with another calcification.These are of unknown origin.These may contribute to pain and stiffness.The report also notes that the patient recently struck the knee on wood.This could cause the swelling.Medical records were not provided.It was reported that the patient hit his knee to wood but we don¿t know what exactly caused it.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.

Event Description

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

• Brand Name: VANGUARD CR ILOK FEM-RT 60
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11266000
• MDR Text Key: 229873826
• Report Number: 0001822565-2021-00300
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

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 Expiration Date: 09/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 183004
• Device Lot Number: 640350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 01/26/2021; 03/30/2021
• Supplement Dates FDA Received: 02/16/2021; 03/31/2021
• 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