MAUDE Adverse Event Report: BIOMET UK LTD. OSFORD PARTIAL KNEE SYSTEM SIZE E LEFT MEDIAL TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reportedly available for evaluation; however, it has not been received by biomet to date.In the event that the device is received and evaluated, a follow-up report will be send to the fda to provide results.

Event Description

It was reported the patient underwent a partial knee arthroplasty on (b)(6) 2016.During the procedure, it was discovered the inner packaging of the implant was damaged.Due to this event, an hour delay occurred.The procedure was completed with another implant.

Manufacturer Narrative

This follow up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.(b)(4).Review of manufacturing history revealed no evidence of product nonconformance and the device likely left the manufacturer conforming to print.Examination of the returned device revealed the packaging was heavily damaged on one corner, which resulted in damage to the blister.There was also evidence of movement of the pouch inside the blister, which damaged both the secondary and primary sterile barriers.The most likely root cause of the event is excessive handling and transportation.

• Brand Name: OSFORD PARTIAL KNEE SYSTEM SIZE E LEFT MEDIAL TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5564080
• MDR Text Key: 42214007
• Report Number: 3002806535-2016-00181
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 154726
• Device Lot Number: 2696348
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR