MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) omar k.Alnachoukati, ms , john w.Barrington, md , keith r.Berend, md , michael c.Kolczun, md , roger h.Emerson, md , adolph v.Lombardi jr., md, david r.Mauerhan, md.(2017) eight hundred twenty-five medial mobile-bearing unicompartmental knee arthroplasties: the first 10-year us multi-center survival analysis.The journal of arthroplasty, 2017,https://doi.Org/10.1016/j.Arth.2017.10.015 reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.

Event Description

Information received based on review of a journal article, entitled "eight hundred twenty-five medial mobile-bearing unicompartmental knee arthroplasties: the first 10-year us multi-center survival analysis" by omar k.Alnachoukati et al.(2017) this complaint refers to the reported 5 oxford knee revision surgeries due to tibial and femoral loosening.There were reported 3 revisions in clinic 1 and 2 revisions in clinic 4.(table 1, page 4).

Manufacturer Narrative

Upon receipt of additional information, it has been determined that these events have previously be submitted via the following submissions: 3002806535-2016-00428, 3002806535-2016-00429, 3002806535-2016-00467, 3002806535-2016-00489, 3002806535-2016-00508.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7199630
• MDR Text Key: 97600177
• Report Number: 3002806535-2018-00126
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention