MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 4710500394-3

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/25/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Device not evaluated as the reference and batch numbers were not communicated, and device was not returned to manufacturer.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.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during the surgery a cemented orthopedic prothesis was implanted on (b)(6) 2019.Patient's blood pressure dropped.Bradycardia and death occured on (b)(6) 2019.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.An investigation has been performed, consisting of a documentary review and of the testing of a retained sample of the same batch than the involved device.The review of the product manufacturing records and the sterilization certificate showed that products were manufactured according to the pre-defined specifications of zimmer biomet.The review of the raw material certificates demonstrate that the raw materials were complying to specifications.The analysis of the retained sample did not show any unusual observation during mixing, handling or setting.The review of the complaint history showed that this is the only death event for the involved batch of products.The surgical notes and the patient medical records were not communicated, however the most probable root cause of the event is the bone cement implantation syndrome.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 a cemented orthopedic prothesis was implanted on (b)(6) 2019.Patient's blood pressure dropped.Bradychardia and death occured on (b)(6) 2019.

• Brand Name: OPTIPAC 40 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: 8599661
• MDR Text Key: 144703303
• Report Number: 3006946279-2019-00253
• 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
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 4710500394-3
• Device Lot Number: 817AA01380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 65