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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: vanguard ssk femur catalog # 185265, lot # 3346324.Vanguard distal femoral augment catalog # 185305, lot # 441240.Vanguard distal femoral augment catalog # 185325, lot # 640430.Biomet splined knee stem catalog # 141618, lot # 021100.Biomet tibial tray catalog # 185203, lot # unknown.Biomet knee stem catalog # 148146, lot # 854590.Biomet offset adapter catalog # 185210, lot # 219010.Biomet tibial sm cruciate wing catalog # 185650, lot # 856820.Customer has indicated that the product will not be returned because it remains implanted.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: 0001825034-2019-02815.Remains implanted.

Event Description

It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient was experiencing pain post operative.The patient reported ongoing moderate to severe knee pain at each annual visit with a decrease in knee flexion.No revision procedure has been reported to date.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

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.Medical records review indicates that the patient sustained a fall due to unknown reasons.Since the reason is unknown, the device cannot be ruled out as the cause of the fall.However, no injury to patient or device was noted, and there is no report of intervention for treatment.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: VANGUARD SSK PS TIBIAL BEARING
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8749542
• MDR Text Key: 149680113
• Report Number: 0001825034-2019-02825
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2018
• Device Model Number: N/A
• Device Catalogue Number: 185086
• Device Lot Number: 760170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 136