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

Model Number	N/A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Joint Laxity (4526)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, h2, h3, h6.The reported event was confirmed by review of the provided medical records and returned product.The femoral component remains implanted and was not returned, however the femoral locking screw was returned.Visual evaluations found the threads are stripped.Visual examination of the bearing found signs of use, nicked and gouged.The locking bar was returned, however it was damaged during removal and no further evaluation was performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records and radiographs were provided and reviewed by a healthcare professional.Review of the records identified that patient was negative for infection.Proximal and lateral heterotopic bone was excised; laxity identified, and no intraoperative complications were reported.Radiographs found no evidence of fracture or implant loosening.A radio-opaque object is noted posterior to the femoral implant consistent with the displaced screw.A definitive root cause cannot be determined for the disassociated screw and wear to the bearing.Failure to replace the femoral stem screw during the procedure can be attributed to a failure to follow instructions.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.
Event or Problem Description
No additional information to report.

• Brand Name: VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM
• Common Device Name: 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
• Report Number: 0001825034-2023-02969
• Device Sequence Number: 14842166
• Product Code: JWH
• UDI-Device Identifier: 00880304441194
• UDI-Public: (01)00880304441194(17)211003(10)616140
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K042757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 05/14/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/12/2024; 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG