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

Catalog Number 110034355

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned to the manufacturer as cement remains implanted.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the raw material certificate shows no non conformity or deviation.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 patient underwent right total knee arthroplasty (b)(6) 2019.Subsequently, patient has had pain, difficulty walking (limps) and limited range of motion since her procedure.She had allergy testing and was told she is quite possibly allergic to the bone cement.She requested material composition for all devices to provide to her allergist.

Manufacturer Narrative

(b)(4).D11 - list of associated devices: - femur cemented posterior stabilized (ps) narrow right size 7, reference (b)(4), batch 64275640.- tibia cemented 5 degree stemmed right size d, reference (b)(4), batch 64286423.- stem extension tapered cemented 14 mm diameter +30 mm length, reference (b)(4), batch 64358764.- all-poly patella cemented 29 mm diameter, reference (b)(4), batch 64358564.- articular surface fixed bearing posterior stabilized (ps) right 10 mm height, reference (b)(4), batch 63997324.- refobacin bc r 1x40 us, reference (b)(4), batch 828fad1611.This follow-up report is being submitted to relay additional information.The following section has been updated : b4, b5, d11, g4, g7, h2, h6, h10.No further information provided (x-rays, surgical report, photographs, lab test).The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The review of the raw material certificate shows no non conformity or deviation.The instruction for use has been reviewed and it was noticed that the cement composition is mentioned in the ifu.Moreover, it is mentioned that the cement should not be used in case of know hyper-sensitivity to one of its component.A complaint extract was done regarding allergy, pain: - 2 complaints (2 products), this one included, have been recorded on refobacin bone cement r 1x40 us, reference (b)(4), from january 01, 2017 to february 01, 2021.- 1 complaint (1 product), this one included, has been recorded on refobacin bone cement r 1x40 us, reference (b)(4), batch 818eak2709.According to available data, the most probable root cause of the event could be patient condition.Indeed, the patient was tested positive for a particular ingredient used in the cement only after the surgery.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 patient underwent right total knee arthroplasty on (b)(6) 2019.Subsequently, patient has had pain, difficulty walking (limps) and limited range of motion since her procedure.She had allergy testing and was found positive for a particular ingredient used in refobacin bone cement.

• Brand Name: REFOBACIN BONE CEMENT R 1X40 US
• 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: 10709846
• MDR Text Key: 212257367
• Report Number: 3006946279-2020-00212
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 818EAK2709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 86