MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST SIZE F 17 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: south africa.Customer has indicated that the product will be 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 patient was revised approximately two months post implantation due to dislocation of the articular surface.The peg that screws into the femur was stripped and not locked in anymore.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No additional information.
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.No product, pictures, or medical records were provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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 is being submitted to relay additional information.Visual examination of the returned product identified sign of being implanted.The hinge post extension exhibits damaged threads, crests are rolled over and stripped/ gouged.A definitive root cause cannot be determined.Complaint is confirmed based on product evaluation.If any further information is received 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 WITH HINGE POST SIZE F 17 MM HEIGHT
• 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: 14931566
• Report Number: 0001822565-2022-01982
• Device Sequence Number: 16641640
• Product Code: JWH
• UDI-Device Identifier: 00889024199446
• UDI-Public: (01)00889024199446(17)240430(10)64382625
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00588006017
• Device Lot Number: 64382625
• 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: 06/12/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 12/07/2023
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 11/04/2022; 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male