MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK 360 R FEM 80MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that when the surgeon opened the implant, the sterile packaging was damaged and sterility of the device was compromised.A new device was opened, however, this resulted in a surgical delay of 35-40 minutes.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product found that the inner cavity was cracked and sterility was breached.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when leaving zimmer biomet was conforming to specifications.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VNGD SSK 360 R FEM 80MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9246136
• Report Number: 0001825034-2019-04663
• Device Sequence Number: 16245456
• Product Code: JWH
• UDI-Device Identifier: 00880304481985
• UDI-Public: (01)00880304481985
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 185270
• Device Lot Number: 3825083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other