MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM RIGHT MEDIAL TIBIAL TRAY SIZE C; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that during a knee arthroplasty surgery, the product was opened and the packaging was found to be unsealed.The surgery was completed with another device.

Manufacturer Narrative

(b)(4).Visual inspection of the returned inner product packaging found that the inner bag is still sealed around the tibial tray.The blister and tyvek lid were not returned for evaluation therefore it is unknown if the blister was sealed.The reported event is non-verifiable as the returned packaging was found to be sealed and not all packaging was returned.Review of the device history records identified no related deviations or anomalies.Further evaluation cannot be performed at this time without the return of the tyvek lid and blister.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: OXFORD PARTIAL KNEE SYSTEM RIGHT MEDIAL TIBIAL TRAY SIZE C
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 6265510
• MDR Text Key: 65350700
• Report Number: 3002806535-2017-00032
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PP010014
• 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: 05/09/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 251940
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1