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

Catalog Number REFOBACIN BONE CEMENT R

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 06/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.[(b)(4)].

Event Description

It was reported revision surgeries in the journal article "minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term": the revisions were due to a progression of arthritis in 5 patients, associated to a persistence of pain in 3 patients, infection or wound dehiscence in 3 patients, aseptic loosening in 2 patients, bearing dislocation in 2 patients, and breakage of the bearing in 1 patient.The current complaint is related to a revision due to the breakage of the bearing for one patient.Journal article: tilman walker, pit hetto, thomas bruckner, tobias gotterbarm, christian merle, benjamin panzram moritz m.Innmann, babak moradi,(2018) minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term.Knee surgery, sports traumatology, arthroscopy https://doi.Org/10.1007/s00167-018-5299-2.

Event Description

It was reported revision surgeries in the journal article "minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term" : the revisions were due to a progression of arthritis in 5 patients, associated to a persistence of pain in 3 patients, infection or wound dehiscence in 3 patients, aseptic looseneing in 2 patients, bearing dislocation in 2 patients, and breakage of the bearing in 1 patient.Refobacin bone cement r was used in the initial surgeries.The current complaint was initially reported as related to a revision due to the breakage of the bearing for one patient.However, it is related to the revisions due to aseptic loosening in 2 patients.Journal article: tilman walker, pit hetto, thomas bruckner, tobias gotterbarm, christian merle, benjamin panzram moritz m.Innmann, babak moradi,(2018) minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term.Knee surgery, sports traumatology, arthroscopy https://doi.Org/10.1007/s00167-018-5299-2.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : d1, g4, h2, h6, h10.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality can't be performed as the product batch number was not communicated.The complaint data review regarding the batch number can't be performed as it was not communicated.10 complaints have been recorded for refobacin bone cement r-1 (all references) within one year.According to available data, the exact root cause can¿t be determined.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 revision surgeries in the journal article "minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term" : the revisions were due to a progression of arthritis in 5 patients, associated to a persistence of pain in 3 patients, infection or wound dehiscence in 3 patients, aseptic looseneing in 2 patients, bearing dislocation in 2 patients, and breakage of the bearing in 1 patient.Refobacin bone cement r was used in the initial surgeries.The current complaint is related to the revisions due to aseptic loosening in 2 patients.Journal article: tilman walker, pit hetto, thomas bruckner, tobias gotterbarm, christian merle, benjamin panzram moritz m.Innmann, babak moradi,(2018) minimally invasive oxford unicompartmental knee arthroplasty ensures excellent functional outcome and high survivorship in the long term.Knee surgery, sports traumatology, arthroscopy.

• Brand Name: REFOBACIN BONE CEMENT R- 1
• 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: 8673050
• MDR Text Key: 147168003
• Report Number: 3006946279-2019-00282
• 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,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REFOBACIN BONE CEMENT R
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention