MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the device would not seatmating implant during surgery.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: type of investigation - 4114 - device not returned is n/a which was reported on initial report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use and the locking feature is flared.Additional information does not affect the root cause.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: ARTICULAR SURFACE
• 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: 14434371
• Report Number: 0001822565-2022-01417
• Device Sequence Number: 5579071
• Product Code: JWH
• UDI-Device Identifier: 00889024634923
• UDI-Public: (01)00889024634923(17)261130(10)64242360
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2022

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: 00596403210
• Device Lot Number: 64242360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 08/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/08/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown