MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 2X40G; BONE CEMENT, ANTIBIOTIC

Catalog Number 4003940002

Device Problems Naturally Worn (2988); Therapeutic or Diagnostic Output Failure (3023); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item number: 00598605702; item name : non-augmentable stemmed tibial component option size 8; item batch: 62133498; handled in (b)(4); item number: 00596401751; item name: femoral component option size g left; item batch: 62254530; handled in (b)(4); item number: 00596405010; item name: articular surface size gh 10 mm height; item batch: 62412557; handled in (b)(4); item number: 00597206538; item name: all poly patella size 38 mm dia.Standard 9.5 mm thickness; item batch: 62413073; handled in (b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported that it has been reported that a revision due to infection was performed following a total left knee replacement on (b)(6) 2018, and a spacer k and 4 grams of vancomycin with cement was placed during this revision surgery.The second stage revision was planned on (b)(6) 2018 to remove the spacer and to place the implant.It was noticed an implant loosening with evidence of wear of the polyethylene insert and evidence of device pitting.

• Brand Name: REFOBACIN BONE CEMENT R 2X40G
• 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: 8404240
• MDR Text Key: 138251317
• Report Number: 3006946279-2019-00169
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 07350023774130
• UDI-Public: (01)07350023774130
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 4003940002
• Device Lot Number: 235BAE2108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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