MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC BONE CEMENT, ANTIBIOTIC

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device not returned because implanted.

Event Description

It was reported by the journal article ( published online : 9 may 2016) referenced below that a femoral loosening without revision occurred after a unicompartmental knee arthroplasty (uka) using a oxford implant. The aim of this article is to compare the cemented oxford uka and the cementless oxford uka. In this study, oxford implant and optipac products were used. Journal article reference : " cementless versus cemented oxford unicompartmental knee arthroplasty : early results of a non-designer user group", b. Kerens,mgm schotanus and al, european society of sports traumatology,knee surgery, arthroscopy ( esska), 2016 (7 pages).

• Brand Name: OPTIPAC
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: hélène bataille ; plateau de lautagne bp75; valence 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 7206084
• MDR Text Key: 97758614
• Report Number: 3006946279-2018-00017
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,LITERATURE

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/19/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/17/2019
• 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

Patient TREATMENT DATA

Date Received: 01/19/2018 Patient Sequence Number: 1

Treatment

OXFORD UNICOMPARTIMENTAL