MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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 after trialing femur with a size 75, surgeon attempted to place femoral implant and it was found that the femoral implant was too large to fit into the prepared site.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.Medical products- biomet finned pri stem 40mm, catalog # 141314, lot # 624540.Ti low profile screw, catalog # 103535, lot # 772550.Biomet series a patella, catalog # 185187, lot # 618240.Biomet por pri tibial tray, catalog # 141266, lot # 326050.Vanguard tibial bearing, catalog # ep-183562, lot # 470710.Palacos bone cement, catalog # 00-1113-140-01, lot # 87744708.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device show nicks, dings, and light scratches.Dimensional analysis was performed and it was noted that measurements taken were as per print specifications.Dhr was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: VANGUARD CR FEMORAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7336175
• MDR Text Key: 102347008
• Report Number: 0001825034-2018-01686
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 183054
• Device Lot Number: 232940
• Other Device ID Number: (01) 0 0880304 27064 0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 06/26/2018; 06/26/2018
• Supplement Dates FDA Received: 06/28/2018; 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 176