MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-RT 72.5; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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: 0001825034-2021-00317.

Event Description

It was reported that the patient underwent a right total knee arthroplasty.A year post implantation, the patient underwent separate revisions of the patellar implant and tibial bearing.Approximately 6 years later, the patient underwent a poly exchange due to aseptic loosening following a fracture of the poly bearing post.The patient then underwent a fourth revision due to fracture of the poly bearing post and instability approximately 5 years later.During the revision, extensive scar tissue was removed, and a new femoral component and bearing was placed without complication.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, this device was determined to be not reportable.The initial report should be voided.

Event Description

Upon receiving additional information of the reported event, this device was determined to be not reportable.The initial report should be voided.

• Brand Name: VAN PS OPEN INTL FEM-RT 72.5
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11267131
• MDR Text Key: 229883501
• Report Number: 0001825034-2021-00318
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

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: 01/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 183113
• Device Lot Number: 969040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN TIBIAL COMPONENT; UNKNOWN TIBIAL COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 127