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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); 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.

Event Description

Revision due to unknown reason.16 patients involved.The revision of surgery was 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.It has been reported that 5 patients underwent revision due to arthritis, in the journal article: marcus r.Streit , julia strew, tilman walker ,thomas bruckner j.Philippe kretzer, volker ewerbeck, christian merle,peter r.Aldinger, tobias gotterbarm (2017) minimally invasive oxford medial unicompartmental knee arthroplasty in young patients.Knee surg sports traumatol arthrosc 25,660-668.Https://www.Ncbi.Nlm.Nih.Gov/pubmed/25957605.The current complaint is related to a revision for the first patient.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction information.Section b5 was updated.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.It was initially reported that the current complaint was related to a revision for the first patient due to a progression of arthritis.The current complaint is actually related to 2 patients who underwent revision surgery due to progression of arthritis with no associated complications.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

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : b5, g4, g5, h2, h6, h10.No x-rays were provided, the complaint could not be confirmed.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.10 similar complaints (including the current complaint) have been recorded regarding a "revision" on refobacin bone cement r-1 (all references) products since 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 (investigated in cmp-(b)(4).), due to a persistence of pain in 3 patients (investigated in cmp-(b)(4).), due to infection or wound dehiscence in 3 patients (investigated in cmp-(b)(4).), due to aseptic looseneing in 2 patients (investigated in cmp-(b)(4).), due to bearing dislocation in 2 patients (investigated in cmp-(b)(4).), and due to breakage of the bearing in 1 patient (investigated in cmp-(b)(4).).The current complaint is related to revisions due to progression of arthritis for the five 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.

• Brand Name: REFOBACIN BONE CEMENT R
• 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: 8669426
• MDR Text Key: 147027604
• Report Number: 3006946279-2019-00274
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• 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 Model Number: N/A
• 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: 09/16/2019
• 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