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.

Event Description

Please refer to report 3006946279-2018-00148.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.  the investigation showed that the first biomet cement was put in the market in 2006, however, the surgery was performed before, in (b)(6) 2005.Therefore, despite the fact that the complaint description mentions an optipac refobacin plus bone cement, the affected cement can not be a biomet bone cement.According to research and development review of the provided technical report, the connection between bone and cement and between cement and implant is satisfactory, so there is no cement malfunction.However, it can be seen that cement dissociated from implant at some time, most probably caused by the use of less cement by the surgeon on the posterior face.No cement deficiency could be observed.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.

• 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
• 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
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR
• Patient Weight: 109