MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL 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)(6).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 arthroplaties: 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 arthroplaties: the first 10-year us multi-center survival analysis" by omar k.Alnachoukati et al.(2017).This complaint refers to the reported 1 oxford knee revision surgery due to tibial fracture, loosening.It was reported 1 revision in clinic 1, (table 1, page 4).

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this event has previously been reported via the following submission: 3002806535-2016-00495.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7203294
• MDR Text Key: 97721806
• Report Number: 3002806535-2018-00142
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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: 01/18/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention