MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE REGULAR CONSTRAINT SZ GREEN/C-H 9MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the articular surface would not seat in the tibial component.Inspection of the articular surface showed damage after several insertion attempts.
Additional Manufacturer Narrative
(b)(4).Report source: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01783.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified signs of use.Flared damage was seen on the dovetail feature.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.The complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.A summary of the investigation was sent to the complainant conveying observations of the supplied photographs.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 REGULAR CONSTRAINT SZ GREEN/C-H 9MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14680086
• Report Number: 0001822565-2022-01761
• Device Sequence Number: 5083793
• Product Code: JWH
• UDI-Device Identifier: 00889024644496
• UDI-Public: (01)00889024644496(17)290330(10)65071195
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 08/04/2022

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: 90597004009
• Device Lot Number: 65071195
• Was Device Available for Evaluation?: No
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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
• 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: Unknown