MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM LEFT MEDIAL MEDIUM 6M; PROSTHESIS, KNEE

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

During a right partial knee arthroplasty, a left meniscal bearing was implanted instead of a right.There was no discrepancy with the packaging or the implant.No additional information is known.

Manufacturer Narrative

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

Event Description

During a right partial knee arthroplasty, a left meniscal bearing was implanted instead of a right.There was no discrepancy with the packaging or the implant.There is no intervention planned as the patient has not experienced any complications.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM LEFT MEDIAL MEDIUM 6M
• 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 ; 0441656655
• MDR Report Key: 6057528
• MDR Text Key: 58399307
• Report Number: 3002806535-2016-00799
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/27/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 159550
• Device Lot Number: 3693790
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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