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

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).List of associated devices: lps flex femoral component, reference 00596801652.Articular surface use with lps, reference 00596204010.Stemmed tibial component precoat size 5, reference 00598004701, handle in (b)(4), medwach report 0001822565-2020-02617.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record could not been reviewed as the reference and the lot number were not communicated.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 been reported that a patient had an initial total knee arthroplasty on (b)(6) 2014.Subsequently, the patient was revised on (b)(6) 2015 due to pain and tibial loosening.The current report handle the cement revised.

Event Description

It was been reported that a patient had an initial total knee arthroplasty on (b)(6) 2014.Subsequently, the patient was revised on (b)(6) 2015 due to pain and tibial loosening.The current report handle the cement revised.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product was not returned, no pictures and x-ray received.Therefore, the reported 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 reference and batch number was not communicated.A complaint extract was done regarding revision due to pain and loosening: 14 complaints (319 products), this one included, have been recorded on refobacin bone cement r -1, from january 01, 2017 to october 15, 2020.The complaint history, regarding the reference number, can't be performed as it was not communicated.The complaint history, regarding the batch number, can't be performed as it was not communicated.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.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-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: 10378777
• MDR Text Key: 202516029
• Report Number: 3006946279-2020-00151
• 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,study
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 65