MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS+ TIB BRG 63/67X14; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Implant date: unknown.Medical product: van ps open intl fem-rt 62.5 catalog # 183106 lot # j3806203u.Series a pat std 31 3 peg catalog # 184764 lot # 762760.Biomet cc cruciate tray 67mm catalog # 141232 lot # j3975122.1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 564750.Biomet cc cruciate tray 67mm catalog # 141232 lot # j3913058.Bmet regenx pri tib tray 67mm catalog # 141272 lot # 620280.Biomet finned pri stem 40mm catalog # 141314 lot # 058730.Series a pat thn 31 3 peg catalog # 184784 lot # 987200.Customer has indicated that the product will not be returned because requested but not returned by hospital.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Visual examination of the provided photo found no damage to the articular surface.Device history record (dhr) was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a revision post implantation due to unstable knee.Articular surface prosthesis was exchanged.Attempt for further information has been made, but no further information has been provided.

• Brand Name: E1 VNGD PS+ TIB BRG 63/67X14
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12408478
• Report Number: 0001825034-2021-02490
• Device Sequence Number: 14498645
• Product Code: JWH
• UDI-Device Identifier: 00880304541085
• UDI-Public: (01)00880304541085(17)201027(10)848480
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 10/27/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-183724
• Device Lot Number: 848480
• 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: 08/10/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 82