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

Catalog Number	110036368
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: 110036368,lot y18aad0605,biomet bc r 1x40 us, 141232,biomet cc cruciate tray 67mm,lot j7548277, 183006,vanguard cr ilok fem-rt 62.5,lot j7615026, 183422,vngd cr tib brg 12x63/67,lot 65860478, 11-150825,bmet arcom ap pat w/wire 28mm,lot 66776976, 414-702,clearmix single/double 10pk,lot 32565.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 the patient developed pain and suffering and mechanical symptoms in the right knee following a total knee arthroplasty.No intervention has been reported to date.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• 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 26903 ; FR 26903
• 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: 25270644
• Report Number: 3006946279-2026-00026
• Device Sequence Number: 15889224
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)240531(10)AZ50BA2102
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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?: No
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 110036368
• Device Lot Number: AZ50BA2102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2021
• 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: Other
• Patient Sex: Male