MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW SIZE GREEN/E F 23 MM HEIGHT; PROSTHESIS, KNEE

Model Number	5994-40-23
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).The customer has indicated that the product is in the 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 that the patient underwent an initial knee procedure.Six months post implantation, the patient experienced a sudden locking of the knee while descending stairs.The patient was subsequently revised two weeks later and the articular surface was replaced without incident.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to be determined.Per package insert, poor range of motion is a known adverse effect of the system.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 at time of this report.

• Brand Name: ARTICULAR SURFACE WITH LOCKING SCREW SIZE GREEN/E F 23 MM HEIGHT
• 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: 12885333
• Report Number: 0001822565-2021-03416
• Device Sequence Number: 19839828
• Product Code: JWH
• UDI-Device Identifier: 00889024225152
• UDI-Public: (01)00889024225152(17)250430(10)63624176
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 02/28/2022

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: 04/30/2025
• Device Model Number: 5994-40-23
• Device Catalogue Number: 00599404023
• Device Lot Number: 63624176
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN FEMORAL COMPONENT: CATALOG#NI, LOT#NI
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 125 KG