MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 12 MM HEIGHT "USE WITH PLATE 5; INSTRUMENT, 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	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: china.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 the 12mm articular surface did not assemble to the tibial tray.A second articular surface was opened and assembled to the tibial tray to complete the procedure satisfactorily.No additional information is available.
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.Visual examination of the returned product identified signs of use and dovetail feature was flared.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were not provided.Complaint is confirmed based on the product evaluation.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: ARTICULAR SURFACE SIZE EF 12 MM HEIGHT "USE WITH PLATE 5
• Common Device Name: INSTRUMENT, 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: 17596183
• Report Number: 0001822565-2023-02232
• Device Sequence Number: 20466650
• Product Code: JWH
• UDI-Device Identifier: 00889024635005
• UDI-Public: (01)00889024635005(17)280725(10)64820803
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 00596404012
• Device Lot Number: 64820803
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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 Age: 58 YR
• Patient Sex: Female