MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD ANT STBLZD BRG 12X63; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vngd ant stblzd brg 12x63; p/n: 189022, l/n: 750670.Vanguard cr ilok fem-lt 60; p/n: 183024, l/n: j6497587.Biomet cc i-beam tray 63mm; p/n: 141221, l/n: j6383477.Series a pat std 31 3 peg; p/n: 184764, l/n: 508290.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04675, 0001825034 - 2019 - 04677, 0001825034 - 2019 - 04678.

Event Description

It was reported the patient had pain at lateral tibial plateau, plus joint line and condyle with limited extension three (3) months after manipulation procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated via medical records and the reported event was confirmed.Medical records were provided and reviewed by a health care professional.Pain was noted at lateral tibial plateau, joint line and condyle.Normal laxity and alignment.Patient lacks in extension.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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

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

• Brand Name: VNGD ANT STBLZD BRG 12X63
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9197620
• MDR Text Key: 166309569
• Report Number: 0001825034-2019-04673
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 189022
• Device Lot Number: 750670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 75