MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40 US; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Edema (1820); Fall (1848); Failure of Implant (1924); Pain (1994)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event occurred in united states.Devices investigated in (b)(4) : ref : (b)(4) name : prc agmt block dist sz e5mm lot : 61822489.Ref : (b)(4) name : stemmed tibial component lot : 64394387.Ref : (b)(4) name : stem extension sharp fluted 16mm dia x 75mmlength lot : 63580188.Ref : (b)(4) name :offset stem impl18mmx200mm lot : 62911816.Ref : (b)(4) name : lcck fem implant sz e-r lot : 64434949.Ref : (b)(4) name : lcck art surf ef 5-6/grn 20 lot : 63857712.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 the patient underwent a second knee revision surgery due to loosening of the tibial and femoral component.Subsequently, the patient required a third knee revision surgery due to pain, instability, loosening of the tibial and femoral component.The patient fell, slipped shortly after the second knee revision.No additional patient consequences were reported.

Event Description

It was reported the patient underwent a second knee revision surgery due to loosening of the tibial and femoral component.Subsequently, the patient required a third knee revision surgery due to pain, instability, loosening of the tibial and femoral component.The patient fell, slipped shortly after the second knee revision.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The review of the op notes of the first revision surgery ((b)(6) 2019) showed that the cement was implanted at the level of the tibial component.It was indicated that the cement was left behind and easily chipped away.Then, during the same surgery, the surgeon cemented the tibial and the femur.The review of the op notes of the second revision surgery ((b)(6) 2020) showed that the femoral component was lightly cemented at the femoral condylar surfaces and the flange as well as up to only the junction of the stem and the housing of the femoral component.It was also noticed that the remainder of the femoral component was not fixated as there was any cement remaining on the host bone.The surgeon supposed that the cement did not integrate well as there was likely sclerotic bone.Regarding the tibial part, it was noticed by the surgeon that there was no cement remaining on the host bone.The product analysis can't be performed as the product was not returned.A retain sample of batch 818eak2709 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).It was noticed that the handling behavior was as expected, a little bit too long (+45¿) but the product was at 22.5°c, which prolonged the setting time as 23°c.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The review of the associated components used with the cement has been performed and it was found that they can be cemented.A complaint extract was done regarding revision due to loosening, instability and pain: 2 complaints (2 products), this one included, have been recorded on refobacin bone cement r 1x40, reference 110034355, from january 01, 2017 to november 02, 2020.1 complaints (1 products), this one included, have been recorded on refobacin bone cement r 1x40, reference 110034355, batch 818eak2709.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 1X40 US
• 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: 10545757
• MDR Text Key: 207296849
• Report Number: 3006946279-2020-00162
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: 0880304990197
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: 818EAK2709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 73