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

Catalog Number OPTIPAC

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record could not been reviewed as the lot number was not communicated.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 knees were revised during the follow-up period.The reason of the revision has not been communcated.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No other information provided (x-ray, surgical report, photographs, lab test).Therefore, the reported event could not be confirmed.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record could not been reviewed as the item number and the lot number were not communicated.Within 3 years, 3 complaints (involving 6 products) have been recorded on optipac refobacin bone cement r regarding revision.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.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 knees were revised during the follow-up period.The reason of the revision has not been communicated.

• Brand Name: OPTIPAC REFOBACIN BONE CEMENT R-3
• Type of Device: BONE CEMENT, ANTIBIOTICS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9961650
• MDR Text Key: 190646878
• Report Number: 3006946279-2020-00041
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: Lay User/Patient
• Device Catalogue Number: OPTIPAC
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention