MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE G 12 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported the trial would not fit, it was deformed, chipped.
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.This complaint was confirmed by review of returned device.Visual evaluation of the returned product exhibits signs of repeated use, it is nicked and gouged especially the bottom surface features.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product, the dhr review, and the potential field age of the device (18 months).The instruction for use manual instructs to visually inspect devices after each use and cleaning, and to request a replacement if damage or wear is noted that may compromise the function of an instrument.Also the user should check if instruments that form part of a larger assembly assemble readily with mating components.If polymer devices show excessive distortion or are visibly warped, they should be replaced.The root cause of the reported issue is attributed to expected wear and tear from repeated use over time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE G 12 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11130952
• Report Number: 0001822565-2021-00092
• Device Sequence Number: 10971984
• Product Code: HSX
• UDI-Device Identifier: 00880304810006
• UDI-Public: (01)00880304810006(11)190610(10)64224880
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42518100712
• Device Lot Number: 64224880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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