MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00888.Concomitant medical products: tibial articular surface provisional right size ef, item#: 42527000505, lot#: 63743436.The product has been returned to zimmer biomet for investigation.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 that a tasp fractured.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Verified item lot combination and reviewed manufacturing date as returned item # 42527000515 lot # 63681980 exhibits signs of repeated use and the post feature has fractured off all pieces were returned reference attached photographs.The device history records for item # 42527000505 lot # 63743436 were reviewed for deviations and/ or anomalies with no anomalies/ deviations identified.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.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13950131
• Report Number: 0001822565-2022-00887
• Device Sequence Number: 17341535
• Product Code: JWH
• UDI-Device Identifier: 00889024245020
• UDI-Public: (01)00889024245020(10)63681980
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 42527000515
• Device Lot Number: 63681980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Patient Sex: Male