MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SSK 360 FEMORAL COMPONENT 65MM RIGHT WITH SCREW; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: unknown vanguard ssk 360 tibial tray catalog #: ni lot #: ni, unknown vanguard ssk 360 tibial bearing catalog #: ni lot #: ni.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It is reported that the patient underwent an arthroscopic removal of a femoral screw approximately two (2) years following knee arthroplasty to address post-operative fracture and wear.Attempts have been made and no additional information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated through photographic inspection, however, the device fracture could not be confirmed.The photograph of the explanted screw showed wear and damage on the threads of the screw.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: VANGUARD SSK 360 FEMORAL COMPONENT 65MM RIGHT WITH SCREW
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10089526
• Report Number: 0001825034-2020-02118
• Device Sequence Number: 3081512
• Product Code: JWH
• UDI-Device Identifier: 00880304481954
• UDI-Public: (01)00880304481954
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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 Model Number: N/A
• Device Catalogue Number: 185264
• Device Lot Number: 6269979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention