MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40; BONE CEMENT, ANTIBIOTICS

Catalog Number 110034355

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 the patient underwent a cement hip hemi arthroplasty.Canal was prepared and cement was mixed as usual per zimmer biomet guidelines.After awaiting approximatively 22 minutes, the cement had still not hardened, therefore, the stem was removed.Indeed, cement fixation was only on the stem component with zero bone integration, causing a wasted stem due to cement failure.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 and corrected information.D11: associated device : echo hip femoral 11mm, ref: 12-151411, lot: 539080.Centralizer distal positioner, ref: 162657, lot: 677830.The product analysis can't be performed as the product was not returned.Received picture shows the explanted stem with cement on it, however the picture review can't confirm the event.Also, a retain sample of batch: 851dah1704 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding cement paste too short setting time: 1 complaint (1 product), this one included, has been recorded on refobacin bone cement 1x40 us, reference: 110034355, from 1 jan 2017 to 24 nov 2020.1 complaint (1 product), this one included, has been recorded on refobacin bone cement 1x40 us, reference: 110034355, batch: 851dah1704.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 the patient underwent a cement hip hemi arthroplasty.Canal was prepared and cement was mixed as usual per zimmerbiomet guidelines.After awaiting approximatively 22 minutes, the cement had still not hardened, therefore, the stem was removed.Indeed,cement fixation was only on the stem component with zero bone integration, causing a wasted stem due to cement failure.No adverse events have been reported as a result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40
• 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: 10275895
• MDR Text Key: 199675452
• Report Number: 3006946279-2020-00128
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: 0880304990197
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 851DAH1704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSOCIATED PRODUCTS LISTED IN H10.; SEE H10.
• Patient Age: 83 YR