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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 "causes and time of surgical interventions after oxford unicompartmental knee arthroplasty: results of a 15 years vreden institute experience" by kornilov, nn, (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 the following journal article: hasan r mohammad, louise strickland, thomas w hamilton & david w murray."long-term outcomes of over 8,000 medial oxford phase 3 unicompartmental knees¿a systematic review" (2017).Issn: 1745-3674 (print) 1745-3682 (online) journal homepage: http://www.Tandfonline.Com/loi/iort20 report source, foreign ¿ events occurred in (b)(6).As limited information was received from the complainant, the reported events could not be confirmed.As the lot number of the devices are unknown, dhr reviews could not be performed.Root causes could not be determined.If further information is found that would change or alter any conclusions reached, a supplemental approach will be filed accordingly.Zimmer biomet will continue to monitor for trends.

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 "causes and time of surgical interventions after oxford unicompartmental knee arthroplasty: results of a 15 years vreden institute experience" by kornilov, nn, (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.This complaint refers to 3 knee revisions due to fracture of medial tibial/femoral condyle.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• 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: 7258616
• MDR Text Key: 99610280
• Report Number: 3002806535-2018-00267
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• 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
• 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