MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN PLUS BONE CEMENT-3; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 4722502117-3

Device Problems Loose or Intermittent Connection (1371); Improper Chemical Reaction (2952)

Patient Problem Failure of Implant (1924)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Natural tibia cemented 5 degree stemmed left size e, reference (b)(4), batch 64794770.Event occurred in (b)(6).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 during left total knee arthroplasty following implant of the femoral component, in deep flexion position, the femur moved distally.Cement had not adhered to patients bone or femoral implant.Cement time was around 11-12 minutes, when femoral implant became loose and was removed.Surgeon assessed the knee and required to downsize femur to a size 7 left standard trabecular metal implant, which was a better fit.Ultra congruent poly and down sized femur to match the correct size for the tibia.There was a 60 minute delay in the procedure trouble shooting for new femur and re trialing implants.Patients posterior cruciate ligament was sacrificed and used ultra congruent poly instead of cruciate retaining.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated : b4, e1, e3, g3, g6, h2, h6, h10.An analysis of a product with the same reference and batch number has been realized.The product analysis shows that the product is an optipac and the cement is compliant with the specifications.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 during left total knee arthroplasty following implant of the femoral component, in deep flexion position, the femur moved distally.Cement had not adhered to patients bone or femoral implant.Cement time was around 11-12 minutes, when femoral implant became loose and was removed.Surgeon assessed the knee and required to downsize femur to a size 7 left standard trabecular metal implant, which was a better fit.Ultra congruent poly and down sized femur to match the correct size for the tibia.There was a 60 minute delay in the procedure trouble shooting for new femur and re trialing implants.Patients posterior cruciate ligament was sacrificed and used ultra congruent poly instead of cruciate retaining.

Event Description

It was reported that during left total knee arthroplasty following implant of the femoral component, in deep flexion position, the femur moved distally.Cement had not adhered to patients bone or femoral implant.Cement time was around 11-12 minutes, when femoral implant became loose and was removed.Surgeon assessed the knee and required to downsize femur to a size 7 left standard trabecular metal implant, which was a better fit.Ultra congruent poly and down sized femur to match the correct size for the tibia.There was a 60 minute delay in the procedure trouble shooting for new femur and re trailing implants.Patients posterior cruciate ligament was sacrificed and used ultra congruent poly instead of cruciate retaining.

Manufacturer Narrative

This is a combination product: (b)(4).This follow-up report is being submitted to relay additional information.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.No other complaint on patient death following medical: loosening/cement paste too long setting time was recorded on the batch since ever, and no other complaint on patient death following medical: loosening/cement paste too long setting time was recorded on the reference from (b)(6) 2018 to (b)(6) 2021.Reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.According to available data, root cause of the event was unable to be determined.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 80 REFOBACIN PLUS BONE CEMENT-3
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11485453
• MDR Text Key: 266310454
• Report Number: 3006946279-2021-00026
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/30/2021

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: 03/31/2021
• Device Catalogue Number: 4722502117-3
• Device Lot Number: C939A01408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/22/2021; 06/30/2021
• Supplement Dates FDA Received: 04/19/2021; 06/30/2021
• 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): Hospitalization; Required Intervention