MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 3003940001-3

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign, health professional - event occurred in (b)(6).List of associated products : item number 42500606202 item name pfemur cemented posterior stabilized (ps) standard right size 7lot # 64302103; item number 19090127af1 item name hoscillating saw blade zimmerâ®/synthesâ® lot # 372069; item number 12076100ur1 item name reciprocating saw blade zimmer biomet recip lot # 348875; item number 00515048200 item name hip kit lot # 64796937; item number 2557000114 item name pstem extension tapered cemented 14 mm diameter +30 mm length lot # 64359223; item number 42540000032 item name pall poly patella cemented 32 mm diameter lot # 64367722; item number 42532007101 item name pnatural tibia cemented 5 degree stemmed left size e lot # 64367521; item number 42512600812 item name particular surface fixed bearing constrained posterior stabilized (cps) left 12 mm height use with tibia sizes e-f / ps femur sizes 10-11lot # 63904814; item number 42557000114 item name pstem extension tapered cemented 14 mm diameter +30 mm length lot # 64832711; item number 42540000035 item name all poly patella cemented 35 mm diameter lot # 64374887; item number 42532006702 item name ptibia cemented 5 degree stemmed right size d lot # 64355617; item number 42522600510 item name particular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes c-d / ps femur sizes 6-9 lot # 64461648.The device manufacturing quality record indicate 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 a surgery has been performed with rosa knee and persona cps in a patient with rhumatoid arthritis performed bilaterally at one time.The surgery took place as expected, without complications.Doctor reported that this patient would be a challenge due to reduced movement amplitude.She was able to extend her leg only up to 30 degrees and flex her leg up to 70 degrees.According to the doctor, the postoperative period still presented pain of unknown origin which he imagined was due to the surgery.However, as the condition did not evolve, 3 months after surgery he asked the patient to undergo a xray, where he verified the loosening of the prosthesis on both sides, apparently only on the femoral side.As a result, he underwent a series of tests, including mri scans and will soon underwent tests to assess whether there was an infection.

Event Description

It was reported that a surgery has been performed with rosa knee and persona cps in a patient with rhumatoid arthritis performed bilaterally at one time.The surgery took place as expected, without complications.Doctor reported that this patient would be a challenge due to reduced movement amplitude.She was able to extend her leg only up to 30 degrees and flex her leg up to 70 degrees.According to the doctor, the postoperative period still presented pain of unknown origin which he imagined was due to the surgery.However, as the condition did not evolve, 3 months after surgery he asked the patient to undergo a xray, where he verified the loosening of the prosthesis on both sides, apparently only on the femoral side.As a result, he underwent a series of tests, including mri scans and will soon underwent tests to assess whether there was an infection.

Manufacturer Narrative

(b)(4).This follow-up is to relay additional information.No delay occured during the surgery.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 surgery was performed with rosa knee and persona cps in a patient with rheumatoid arthritis performed bilaterally at one time.The surgery took place as expected, without complications.Doctor reported that this patient would be a challenge due to reduced movement amplitude.She was able to extend her leg only up to 30 degrees and flex her leg up to 70 degrees.According to the doctor, his postoperative period still presented pain of unknown origin which he imagined was due to the surgery.However, as the condition did not evolve, 3 months after surgery he asked the patient to undergo an x-ray, where he verified the loosening of the prosthesis on both sides, apparently only on the femoral side.As a result, he underwent a series of tests, including mri scans and will soon undergo tests to assess whether there is an infection.

Manufacturer Narrative

This is a combination product (b)(4).This follow-up is to relay additional information.2 complaints on medical : loosening were recorded on the batch since ever, and 2 complaints on medical : loosening was recorded on the reference from jan 01, 2018 to jan 7, 2022.2 complaints on medical : infection were recorded on the batch since ever, and 3 complaints on medical : infection was recorded on the reference from jan 01, 2018 to jan 7, 2022.X-rays has been received and shows very little cement on the posterior part of the femoral implant.X-rays review stated that bilateral femoral periprosthetic fractures was identified with subsequent loosening.Osteopenia was noted as well.X-ray review showed that an infection was unlikely.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: REFOBACIN BONE CEMENT R 1X40-3
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12777885
• MDR Text Key: 280507856
• Report Number: 3006946279-2021-00194
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 3003940001-3
• Device Lot Number: A941BK1904
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/08/2021; 11/08/2021
• Supplement Dates FDA Received: 12/08/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female