MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; PROSTHESIS, KNEE

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) hasan r mohammad, louise strickland, thomas w hamilton and david w murray (2018) long-term outcomes of over 8,000 medial oxford phase 3 unicompartmental knees¿a systematic review, acta orthopaedica, 89:1, 101-107, doi: 10.1080/17453674.2017.1367577 to link to this article: https://doi.Org/10.1080/17453674.2017.1367577.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer as the lot numbers of the devices are unknown, dhr reviews could not be performed.Root cause could not be determined.If further information is found that would change or alter any conclusions reached, a supplemental report will be filed accordingly.Model #/lot #: error correction.Initial reporter error correction.

Event Description

A journal article entitled "long-term outcomes of over 8,000 medial oxford phase 3 unicompartmental knees¿a systematic review", by mohammad hr, (2017), investigated under (b)(4), was based on a review of 15 other publications.Separate complaints have been raised to investigate journals mentioned in this medical paper.This complaint refers to the study entitled "the twin peg oxford knee: 10 year survivorship and surgical principles." by white, sh, et al.(2016), presented at oxford partial knee 40 year symposium 2016.This journal article could not be located however, the summary of the reported adverse events has been found in the supplemental material within mr mohammad's article.There was reported 1 knee revision due to aseptic loosening.

Manufacturer Narrative

Journal article attached: white sh, et al, the twin peg oxford knee ¿ medium term survivorship and surgical principles, knee (2018), https://doi.Org/10.1016/j.Knee.2018.01.001 (b)(4).

• Brand Name: UNKNOWN OXFORD BEARING
• 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: christina arnt ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7280295
• MDR Text Key: 100412313
• Report Number: 3002806535-2018-00334
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2018
• 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