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

Catalog Number	110035368
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Fatigue (1849); Failure of Implant (1924); Pain (1994); Deformity/ Disfigurement (2360); Ambulation or Postural Difficulties (2544); Decreased Appetite (4569); Joint effusion (4849)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery of a left knee femoral component one year and ten months post initial arthroplasty due to pain, fatigue, and difficulty with daily work activities.Mri demonstrated a cyst-like abnormality and signs comparable with hardware loosening.Intra-operatively a large defect to the medial femoral condyle was noted as well as gross loosening of the femoral component confirmed-the tibial side was found to be solid and therefore remains in place.No complications were reported, and further details have not been provided.
Additional Manufacturer Narrative
(b)(4).D-10: 110035368, biomet bc r 1x40 us, lot ax21ab1101 42502607401, femur cemented cruciate retaining (cr) standard left size 12, lot 65186608 42512101010, articular surface medial congruent (mc) left 10 mm height use with tibia sizes g h/cr femur size 12, lot 65279279 42532008301, tibia cemented 5 degree stemmed left size h, lot 65204461 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4, b4-b7, g3, g6, h1, h2, h10, h11.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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.No products were returned or pictures provided; visual evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations for both products.Review of the complaint histories identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combinations.Medical records/radiographs were provided and reviewed by a health care professional.Reported event was confirmed by review of medical records.Based on the available information, the reported event can be confirmed.With the available information, a definitive root cause could not 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.

• Brand Name: BIOMET BC R 1X40 US
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21760293
• Report Number: 3006946279-2025-00043
• Device Sequence Number: 8766769
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)250430(10)AX20BB1102
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 110035368
• Device Lot Number: AX20BB1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 06/27/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/16/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 147 KG