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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REFOBACIN BONE CEMENT R 1X40 US; BONE CEMENT, ANTIBIOTIC
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REFOBACIN BONE CEMENT R 1X40 US; BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number 110034355
Device Problems Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
Event Date 02/10/2021
Event Type  Injury  
Manufacturer Narrative
This is a combination product (b)(4).Report source heath professional - event occurred in united states.This is a combination product.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 revision (b)(6) 2020 due to tibial loosening.As reported, subsequently, the patient developed pain and underwent a second right tka revision on (b)(6) 2021 due to tibial loosening: the poly and tibial component were revised.In addition it was reported that the tibial component was found grossly loose with varus alignment (related complaint is (b)(4)).As reported the cement used is refobacin bc r 1x40 us ref 110034355 lot 907cai1801.
 
Event Description
It was reported that patient underwent right total knee revision (b)(6) 2020 due to tibial loosening.As reported, subsequently, the patient developed pain and underwent a second right tka revision on (b)(6) 2021 due to tibial loosening: the poly and tibial component were revised.In addition it was reported that the tibial component was found grossly loose with varus alignment (related complaint is (b)(4)).As reported the cement used is refobacin bc r 1x40 us ref 110034355 lot 907cai1801.
 
Manufacturer Narrative
This is a combination product.(b)(4) this follow-up report is being submitted to relay additional information.Op notes from linked complaint (b)(4) were received on 08-sep-2021.These op notes were reviewed and it was noticed that no issue during the use of the bone cement and no abnormal cement behavior was experienced 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 patient underwent right total knee revision (b)(6), 2020 due to tibial loosening.As reported, subsequently, the patient developed pain and underwent a second right tka revision on (b)(6), 2021 due to tibial loosening: the poly and tibial components were revised.In addition it was reported that the tibial component was found grossly loose with varus alignment.As reported the cement used is refobacin bone cement r 1x40 us ref (b)(4) lot 907cai1801.
 
Manufacturer Narrative
(b)(4).D10 - list of associated devices: - femoral component option for cemented use only size f righ, reference (b)(4), batch not communicated - stem extension straight 15mm dia x 30mm length(combined length 75mm), reference (b)(4), batch 62752765 - articular surface use with lps/lps-flex 51 or 52suffix femorals size ef 12mm heigh, reference (b)(4), batch 64687730 - trabecular metala distal femoralaugment block, reference (b)(4), batch not communicated - stem extension straight 15mm dia x 30mm length (combined length 75mm), reference (b)(4), batch 62746050 - trabecular metalâ¿ tibial halfblock augment tapered left lateral/ right medial with screws, reference (b)(4), batch not communicated this follow-up report is being submitted to relay additional information.No picture was received and the product involved was not able to be returned as it remains implanted.X-rays and medical records were requested: the received op notes were reviewed and it was noticed that no issue during the use of the bone cement and no abnormal cement behavior was experienced during the surgery.In addition, the analysis of medical records reported the presence of a thin lucency surrounding the bone cement at the proximal tibial metaphysis is seen, but of uncertain significance.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.A complaint extract was done regarding medical : revision, medical : pain, medical : loosening and medical : malpositioned: - 6 complaints (involving 6 products), this one included, have been recorded on refobacin bone cement r 1x40 us, reference (b)(4), from (b)(6) 2021.- 1 complaint (involving 1 product), this one included, has been recorded on refobacin bone cement r 1x40 us, reference (b)(4), batch 907cai1801, since ever.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.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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.
 
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Brand Name
REFOBACIN BONE CEMENT R 1X40 US
Type of Device
BONE CEMENT, ANTIBIOTIC
MDR Report Key12143134
MDR Text Key260736673
Report Number3006946279-2021-00109
Device Sequence Number1
Product Code MBB
UDI-Device Identifier00880304990197
UDI-Public00880304990197
Combination Product (y/n)N
PMA/PMN Number
K171540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2022
Device Model Number110034355
Device Catalogue Number110034355
Device Lot Number907CAI1801
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight108
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