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

Catalog Number NOT COMMUNICATED

Device Problems Fracture (1260); 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.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.

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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g4, h2, h6, h10.The product was not returned, so the event 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.With the available data, the root cause could not 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.

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.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.

• 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: 8673145
• MDR Text Key: 147165269
• Report Number: 3006946279-2019-00283
• 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
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NOT COMMUNICATED
• Device Lot Number: NOT COMMUNICATED
• 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