MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA

Catalog Number 161469

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - oxf uni tib tray sz c lm pma, item 154727, lot 030700; oxf anat brg rt md size 7 pma , item 159579, lot 319630.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01091 and "3002806535-2018-0100.".

Event Description

It was reported that a patient underwent knee arthroplasty.Subsequently, the patient is being considered for a revision for poly swap due to instability.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD PMA
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7897781
• MDR Text Key: 121015591
• Report Number: 3002806535-2018-01099
• Device Sequence Number: 1
• Product Code: NRA
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 161469
• Device Lot Number: 989290
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 52 YR