MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40; BONE CEMENT, ANTIBIOTIC

Catalog Number 4020830401

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This medwatch report is associated to the medwatch report 0001822565- 2018 -01987 (zimmer biomet reference (b)(4)) related to the same revision surgery concerning a tibial component precoat left medial/right lateral size 2, catalog # 00584200201, lot # 63270273.Report source- foreign.The event occurred in (b)(6).The device was not returned, therefore no product evaluation has been performed.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the product is conform and the root cause is undertemined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that a patient underwent initial knee arthroplasty on (b)(6) 2017.The patient was revised on (b)(6) 2018 to address pain and tibial loosening and/or subsidence.

• Brand Name: REFOBACIN PLUS BONE CEMENT 40
• 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: helene bataille ; plateau de lautagne bp75; valence cedex 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 7403580
• MDR Text Key: 104592289
• Report Number: 3006946279-2018-00139
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 4020830401
• Device Lot Number: A612DF0606
• Other Device ID Number: (01) 07350023774437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention