MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VANGUARD CR TIBIAL BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard cr ilok fem-lt 70 70, catalog #: 183032, lot #: 633940.Biomet cc cruciate tray 75mm mm, catalog #: 141234, lot #: j3081730.Series a pat thn 34 3 peg no/wr, catalog #: 184786, lot #: unknown.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2020-02453, 0001825034-2020-02454.

Event Description

It was reported that patient underwent total left knee arthroplasty.Subsequently, the patient was revised due to implant failure, instability, worse interior flexion and extension.Further, the patient alleges the surgeon stated the knee was loose during the revision procedure.Attempt for further information has been made, but no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The contact was sent the investigation results.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.

• Brand Name: E1 VANGUARD CR TIBIAL BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10195370
• MDR Text Key: 198905062
• Report Number: 0001825034-2020-02451
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-183440
• Device Lot Number: 192970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84