MAUDE Adverse Event Report: BIOMET UK LTD. VG DA 360 O/S TIB TRAY COCR 67; KNEE, PROSTHESIS

Catalog Number 161429

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This product is manufactured by zimmer biomet uk and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet manufactures a similar device that is cleared or distributed in the united states under 510k number k093293.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.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 the product had a crack in the packaging.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the inner cavity confirms it has been damaged.The damage to the cavity has punctured all the way through.Device history record 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.

• Brand Name: VG DA 360 O/S TIB TRAY COCR 67
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7747298
• MDR Text Key: 115935726
• Report Number: 3002806535-2018-00958
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2021
• Device Catalogue Number: 161429
• Device Lot Number: 3796388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1