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	Pain (1994); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported that the patient underwent a left total knee replacement.Approximately one year postoperatively, the patient developed persistent, progressive pain in the left knee.A revision to left total knee arthroplasty was subsequently performed.During the revision procedure, aseptic loosening of the original implants was identified.The original implants and bone cement were removed without difficulty, and it was observed that the bone cement interface had failed.There was minimal bone loss noted during removal of the primary implant and cement.Attempts have been made and no further information could be obtained.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The following sections were corrected: g2.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process.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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22913703
• Report Number: 3006946279-2025-00102
• Device Sequence Number: 15731017
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)240831(10)I1603Y37CA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 08/31/2024
• Device Catalogue Number: 110035368
• Device Lot Number: I1603Y37CA
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White