MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW "SIZE STRIPED YELLOW/E F; 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	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00598003701 - stemmed tibial component - j6940389.00599401591 - femoral component - 64369141.00597206538 - patella - 62851387.00599403214 - articular surface - 63974806.Report source: foreign - (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 total knee arthroplasty was performed with nexgen lcck.During the procedure, a gap gradually generated between the anterior side of the articular surface and tibial plate as the screw was tightened to fix stem extension.Subsequently, another lcck surface was used to complete the procedure.There was a delay in the procedure of 16-30 minutes attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Visual examination of the returned device found the support post base is protruding out of the articular surface.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The 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 report 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 WITH LOCKING SCREW "SIZE STRIPED YELLOW/E F
• 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: 12432839
• Report Number: 0001822565-2021-02501
• Device Sequence Number: 12034017
• Product Code: JWH
• UDI-Device Identifier: 00889024225039
• UDI-Public: (01)00889024225039(17)261130(10)64221034
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/19/2022

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: 00599403212
• Device Lot Number: 64221034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• 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: 08/16/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Age: 89 YR
• Patient Sex: Unknown