MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Laxity (4526)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure post implantation due to pain and instability in knee.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).D10 - medical product: unknown vanguard femur catalog # unknown lot # unknown.Unknown vanguard tibia catalog # unknown.Lot # unknown.Unknown vanguard patella catalog # unknown.Lot # unknown.G2 : australia.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2023-02549.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to lack of medical records and no product or pictures received.Review of the device history records could not be performed as part/lot information was not provided.A definitive root cause could not be determined.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.

• Brand Name: UNKNOWN VANGUARD ARTICULAR SURFACE
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18048520
• MDR Text Key: 327083261
• Report Number: 0001825034-2023-02547
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male