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

Catalog Number OPTIPAC BONE CEMENT PLUS

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). (b)(6). Implant date: 2005. Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were previously filled for (b)(4): 0001825034 -2018 -01577, 0001825034-2018-01579, 0001825034-2018-01324, 0001825034 -2018 -02607.

Event Description

It was reported that the patient underwent an initial knee arthroplasty in (b)(6) 2005, using optipac refobacin plus bone cement. Subsequently, the patient was revised on (b)(6) 2018 due to fracture of the implant, loosening, osteolysis, and wear. The tibial base plate is broken in situ, a significant delamination process was recognized. It was reported an aseptic loosening on the femoral implant and in the ventral area of the tibial base plate. This complaint is related to the complaint (b)(4) recorded on the following products: vngd cr tib brg 14x79/83 catalog # 183464 lot # not communicated, maxim ilok ana pri fml 75 rt catalog # 140014 lot # not communicated, biomet tibial component, catalog #141216 lot# not communicated, biomet finned pri stem 40 mm, catalog # 141314 lot # 789370.

• Brand Name: OPTIPAC REFOBACIN PLUS BONE CEMENT
• 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: 7468320
• MDR Text Key: 106731885
• Report Number: 3006946279-2018-00148
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• Reporter Country Code: AU
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/27/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: OPTIPAC BONE CEMENT PLUS
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• 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: 04/27/2018 Patient Sequence Number: 1