MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 72.5; PROSTHESIS, KNEE

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a total knee arthroplasty the inner and outer packaging of the femoral component had a hole.Another femoral component was available to be used without delay or impact to the patient.

Manufacturer Narrative

Visual evaluation of the returned product confirmed there is a hole through the outer carton and both sterile cavities.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information reported.

• Brand Name: VANGUARD CR ILOK FEM-LT 72.5
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8980159
• MDR Text Key: 158201101
• Report Number: 0001825034-2019-04032
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304449183
• UDI-Public: (01)00880304449183
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• 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: 11/15/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183033
• Device Lot Number: J6535544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1