MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R-3; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 4712500398-3

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign and health professional - event occurred in (b)(6).Concomitant medical products: list of associated products : item number 150372 item name oss cemented im stem 18x150 50 lot # 216090.Item number 150411 item name oss tibial poly bearing 14mm lot # 822750.Item number unknown item name unknown femoral component lot # unknown.Item number unknown item name unknown hinge assembly lot # unknown.Item number unknown item name unknown tibial tray and stem lot # unknown.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.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 revision due to loosening of the femoral cemented stem and wear with fracture of the polyethylene.The cement initially implanted was an optipac 80 refobacin bone cement r-3.

Manufacturer Narrative

This is a combination product (b)(4).G3 - report source, foreign, health professional - event occurred in belgium.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.X-rays were provided and were reviewed by associate director research and development.He did not see any abnormality in the x-rays concerning cement.Radiologist x-rays review concluded for a possible radiolucency at the bone cement interface of the femoral component, with normal bone mineralization.No other complaint on revision was recorded on the batch since ever, and 1 other complaint on revision was recorded on the reference from (b)(6) 2018 to (b)(6) 2021.No other complaint on loosening was recorded on the batch since ever, and 1 other complaint on loosening was recorded on the reference from (b)(6) 2018 to (b)(6) 2021.According to available data, root cause of the event 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 was reported that a patient underwent a revision due to loosening of the femoral cemented stem and wear with fracture of the polyethylene.The cement involved is an optipac 80 refobacin bone cement r-3.

• Brand Name: OPTIPAC 80 REFOBACIN BONE CEMENT R-3
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12688377
• MDR Text Key: 278108418
• Report Number: 3006946279-2021-00184
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 4712500398-3
• Device Lot Number: 812AA09210
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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
• Treatment: SEE H10 FOR ASSOCIATEDPRODUCTS.
• Patient Outcome(s): Required Intervention