MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD PS TIB BEARING 10X87/91MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had a revision procedure 32 months¿ post implantation due to a fractured tibial bearing while manually pulling a heavy trailer.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4), visual examination of the returned product identified signs of being implanted wear/discoloration and the post has fractured off.The post fracture on the item was the result of overloading, possibly exacerbated by impingement from the femoral component, and possibly also exacerbated by misalignment of the femoral with the tibial component.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the complaint is for the cam breaking off of the ps bearing.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VANGUARD PS TIB BEARING 10X87/91MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11266538
• Report Number: 0001825034-2021-00307
• Device Sequence Number: 19123813
• Product Code: JWH
• UDI-Device Identifier: 00880304272095
• UDI-Public: (01)00880304272095(17)200620(10)369590
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 183680
• Device Lot Number: 369590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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