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

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Date 06/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.With the available information, the event could not be confirmed.The review of the device manufacturing quality record indicates that optipac 40 refobacin bone cement r, reference (b)(4), lot number 001bal1403 were manufactured on 2010, 23 april.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.No other similar complaint has been recorded on optipac 40 refobacin bone cement r, reference (b)(4), from (b)(6) 2018 to (b)(6) 2021.No other similar complaint has been recorded has been recorded on optipac 40 refobacin bone cement r, reference (b)(4), batch 001bal1403.With the available information, the exact root cause of the event could not 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 the patient underwent an initial left knee arthroplasty.Subsequently, it was discovered that free cement fragment was blocking the joint.An arthroscopic surgery was performed to remove the loosened cement fragment.No additional patient consequences were reported.

• Brand Name: OPTIPAC
• Type of Device: OPTIPAC 40 REFOBACIN BONE CEMENT R
• 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: 11322109
• MDR Text Key: 231939451
• Report Number: 3006946279-2021-00012
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2011
• Device Model Number: N/A
• Device Catalogue Number: 4710500394
• Device Lot Number: 001BAL1403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 72