MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40X2; BONE CEMENT, ANTIBIOTIC

Catalog Number 3021170001

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

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign: event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.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 arthroplasty.Subsequently, the patient was revised due to tibial and femoral component loosening and suspicion of infection.During revision, infection was confirmed.Patient was treated with a spacer and then, new prothesis was implanted.No additional patient consequences were reported.

Event Description

It was reported that patient underwent right total knee arthroplasty.Subsequently, the patient was revised due to tibial and femoral component loosening and suspicion of infection.During revision, infection was confirmed.Patient was treated with a spacer and then, new prothesis was implanted.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Reported event was confirmed through the x-rays provided.The product analysis couldn't be performed as the products was not returned.The review of the device manufacturing quality record indicates that 594 (of 3076237) products designation refobacin plus bone cement 40x2, reference (b)(4), lot number 144cak2609 were manufactured on 07 august 2013.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The review of the device manufacturing quality record indicates that 399 (of 3110547) products designation refobacin plus bone cement 40x2, reference (b)(4), lot number 144cak2609 were manufactured on 07 august 2013.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.1 complaint has been recorded on refobacin plus bone cement 40x2, reference (b)(4), batch 144cak2609 from 20th november 2020 to 16th november 2016.According to available data, the most probable root cause is undetermined.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.

Manufacturer Narrative

(b)(4).The x-rays received show that a space has been created in the tibial pin, as if the keel had dug out the cement but can't confirmed if the cement behaviour is unusual.The review of the device manufacturing quality record indicates that (b)(4) products refobacin plus bone cement 40x2, reference 3021170001, lot number 144cak2609 were manufactured on 20 june 2013.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The review of the device manufacturing quality record indicates that (b)(4) products refobacin plus bone cement 40x2, reference 3021170001, lot number 144cak2609 were manufactured on 02 august 2013.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.1 complaint included this one have been recorded for refobacin plus bone cement 40x2, reference 3021170001 and batch 144cak2609.According to available data, the 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.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent right total knee arthroplasty.Subsequently, the patient was revised due to tibial and femoral component loosening and suspicion of infection.During revision, infection was confirmed.Patient was treated with a spacer and then, new prothesis was implanted.No additional patient consequences were reported.

• Brand Name: REFOBACIN PLUS BONE CEMENT 40X2
• 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: 9797397
• MDR Text Key: 187913749
• Report Number: 3006946279-2020-00028
• 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,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 3021170001
• Device Lot Number: 144CAK2609
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention