MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM CEMENTLESS LEFT MEDIAL TIBIAL TRAY SIZE D WITH SLOTS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Udi# (b)(4).Pma 510(k): -this device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number p10014.This report was delayed due to an issue with the zimmer biomet network and system database which impacted global regulatory reporting.Acknowledgement was provided by (b)(4) emdr january 5, 2017 of zimmer biomet¿s system downtime.

Event Description

During a left knee hemiarthroplasty the tibial component could not be fully seated, even after the surgeon used greater than normal force to attempt to do so.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM CEMENTLESS LEFT MEDIAL TIBIAL TRAY SIZE D WITH SLOTS
• 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: 6228484
• MDR Text Key: 64036515
• Report Number: 3002806535-2016-00838
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PNA
• 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
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 166576
• Device Lot Number: 3828623
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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: 54 YR
• Patient Weight: 81