MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BC R 1X40 US; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Arthritis (1723); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Joint Laxity (4526)

Event Date 03/06/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a left knee arthroplasty revision approximately four (4) years post-operatively due to pain, instability, femoral loosening, recurrent patellar dislocations and patellar fragmentation.Competitor devices were used to complete the procedure.Revision operative records indicate that the knee joint was grossly unstable to varus-valgus stress and anterior-posterior stress.The femoral component was loose when tapped and the patellar component had uncovered eburnated bone.

Manufacturer Narrative

(b)(4).Concomitant medical products: lps flex femoral component-option for cemented use only nitrogen hardened size e left; item#00596801551; lot#64017665.All poly patella standard size 32 mm diameter 8.5 mm thickness for cemented use only; item#00597206632; lot#64178939.Stemmed tibial component precoat size 3 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten; item#00598003701; lot#64158604.Articular surface use with lps/lps-flex 51 or 52 suffix femorals size ef 12 mm height; item#00596203212; lot#63658236.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.Visual examination of the provided pictures identified that tibial component, femoral component and patella have been cemented and there is traces of bone.A review of the device manufacturing records confirmed no abnormalities or deviations.Device used for treatment.Medical records and radiographs were provided and reviewed from an healt care professionel.It has been identified that; patient suffured from pain, patella dislocation with twisting motion of knee and flexion laxity.The x-ray show an osteolysis to anterior aspect of tibial tray, patella with cystic changes, possible partial separation, sclerotic changes, fragmentation of superior pole of patella, displace 3 mm, and patella alta.It is unclear if patella fragmentation if posttraumatic or not.It has been found that patient was negative for infection or loosening and positive for significant tibial rotation.The patient underwent revision surgery and it was found that joint was grossly unstable to varus-valgus stress and anterior-posterior stress.The femoral component was bubbling loose when tapped.Eburnated bone under patella component.Femur and tibia components excised with minimal bone loss.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: REFOBACIN BC R 1X40 US
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16730083
• MDR Text Key: 313190785
• Report Number: 3006946279-2023-00042
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)201231(10)804BAL1108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: 804BAL1108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 93 KG