MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 4711500396-3

Device Problem Improper Chemical Reaction (2952)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore, it was not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation is in progress.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 during the surgery, the cement hardened too quickly.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device was returned to the manufacturer.Therefore, it will be analyzed.Investigation is in progress.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 during the surgery, the cement hardened too quickly.No adverse events have been reported as a result of the malfunction.

Event Description

It has been reported that during the surgery, the cement hardened too quickly.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The review of the device manufacturing quality can't be performed as the product batch number was not communicated.The product was returned and lab analysis was performed (over the cylinder batch: a924a).The product analysis shows that the returned product is an optipac, only the upper cylinder has been returned.The mixing rod was broken inside the cylinder in upper position.The plunger was unlocked in upper position.The nozzle was assembled.The mixing was homogeneous.The reason why the cement hardened too quickly could not be determined.The reported was not confirmed.No sample test has been performed over the same batch as it has not been communicated.The visual test performed over the received cylinder has been validated conform.As an incomplete device has been returned, we cannot determine the batch number of the product.Three complaints (three products), this one included, have been recorded on optipac 60 refobacin bone cement r-3, reference 4711500396-3, from jan 1st 2018 to march 17, 2021.The complaint history, regarding the batch number, can't be performed as it was not communicated.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.

• Brand Name: OPTIPAC 60 REFOBACIN BONE CEMENT R-3
• 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: 11221649
• MDR Text Key: 229593059
• Report Number: 3006946279-2021-00003
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 4711500396-3
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/26/2021; 02/24/2021
• Supplement Dates FDA Received: 02/22/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1