MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CR RIGHT 14 MM HEIGHT; PROSTHESIS, KNEE

Model Number	42-5210-005-14
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study that a study patient underwent a primary total knee arthroplasty.Approximately sixteen months post-implantation the patient was revised due to instability and the polyethylene insert was exchanged.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femur cemented cruciate retaining (cr) standard right size 8: catalog#42502606402, lot#63947833; tibia cemented 5 degree stemmed right size e: catalog#42532007102, lot#63947833; all poly patella cemented 32 mm diameter: catalog#42540000032, lot#64129910; optipac-s 60 refob bn cmt r: catalog#4711500396-1, lot#a746d06425.Report source: foreign: (b)(6).Customer has indicated that 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: the investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations 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.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CR RIGHT 14 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: 13175959
• Report Number: 0001822565-2021-03721
• Device Sequence Number: 4845476
• Product Code: JWH
• UDI-Device Identifier: 00889024239739
• UDI-Public: (01)00889024239739(17)240831(10)63455026
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2022

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: 08/31/2024
• Device Model Number: 42-5210-005-14
• Device Catalogue Number: 42521000514
• Device Lot Number: 63455026
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 03/22/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/14/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 88 KG