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

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown.Medical product: series a pat thn 31 3 peg catalog # 184784 lot # 987200.Biomet finned pri stem 40mm catalog # 141314 lot # 058730.Van ps open intl fem-lt 65 catalog # 183128 lot # j2954693.Bmet regenx pri tib tray 67mm catalog # 141272 lot # 620280.Biomet cc cruciate tray 67mm catalog # 141232 lot # j3913058.1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 564750.Biomet cc cruciate tray 67mm catalog # 141232 lot # j3975122.Series a pat std 31 3 peg catalog # 184764 lot # 762760.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 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
• Type of Device: 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: 12408573
• MDR Text Key: 269371882
• Report Number: 0001825034-2021-02494
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304641030
• UDI-Public: (01)00880304641030(17)210119(10)799440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-183720
• Device Lot Number: 799440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 82