MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Degraded (1153)

Patient Problems Ossification (1428); Pain (1994); Joint Laxity (4526)

Event Date 11/16/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address pain and femoral screw migration approximately five (5) years post-operatively.During the revision, the tibial bearing was also identified to be damaged from contact with the loose screw.The tibial bearing and locking bar were replaced.The femoral construct remained well-fixed with no signs of loosening, so the surgeon did not feel it was necessary to replace the migrated screw.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - vanguard ssk 360 femoral component right 65mm catalog #: 185264 lot #: 6256720, biomet 360 tibial tray 79mm catalog #: 185205 lot #: 182670, biomet 360 tibial large cruciate wing catalog #: 185651 lot #: 987170, biomet splined knee stem 15mm x 80mm catalog #: 148305 lot #: 115340, biomet 360 2.5mm offset adapter catalog #: 185210 lot #: 711920, biomet splined knee stem 15mm x 120mm catalog #: 148318 lot #: 384280, vanguard series a standard 3-peg patella 37mm catalog #: 184768 lot #: 035180.The product has been received by zimmer biomet and 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 patient; please see all reports associated with this event: 0001825034-2023-02968.

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address pain and femoral screw migration approximately five (5) years post-operatively.During the revision, the tibial bearing was also identified to be damaged from contact with the loose screw.The tibial bearing and locking bar were replaced.The femoral construct remained well-fixed with no signs of loosening, so the surgeon did not feel it was necessary to replace the migrated screw.No additional patient consequences were reported.Initial operative notes noted no intraoperative complications.Revision operative notes noted that the patient had increased laxity in varus and valgus as well as in flexion prior to the tibial bearing being removed.The loosened femoral screw was identified posterior lateral and was removed without difficulty.Heterotopic bone was also identified and removed from the patella.No intraoperative complications were identified.

Manufacturer Narrative

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

• Brand Name: VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM
• 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: 18344089
• MDR Text Key: 330800695
• Report Number: 0001825034-2023-02969
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304441194
• UDI-Public: (01)00880304441194(17)211003(10)616140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: N/A
• Device Catalogue Number: 185102
• Device Lot Number: 616140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2016
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG