MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH PLATE 3,4 SIZE YELLOW/C-H 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: 00595001501-femoral component precoat size e left-63701641.00598003702-stemmed tibial component precoat size 4 for cemented stem-j6576707.42540200032-all-poly patella cemented 32 mm diameter-64501748.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records for [item#: 00595203010 lot#: 64403622] were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: ccr12434151; ccr12429362.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot 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
It was reported the patient underwent a revision knee arthroplasty approximately 18 months¿ post implantation due to instability and hyperextension.The articular surface was replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ARTICULAR SURFACE USE WITH PLATE 3,4 SIZE YELLOW/C-H 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12120515
• Report Number: 0001822565-2021-01811
• Device Sequence Number: 3768793
• Product Code: JWH
• UDI-Device Identifier: 00889024207967
• UDI-Public: (01)00889024207967(17)240531(10)64403622
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00595203010
• Device Lot Number: 64403622
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention