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

Catalog Number	110035368
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).This is combined initial and final mdr report.D10: biomet bc r 1x40 us; item number#: 110035368; lot#: ay48al0703.Biomet bc r 1x40 us; item number#: 110035368; lot#: ay49bl0703.Vg 360 univ pst fm aug 70x5; item number#: 185346; lot#: 138350.Vngd ti fem ssk 70mm lt; item number#: cp113127; lot#: 795410.Bmt splined knee stm v2 20x120; item number#: 148323; lot#: 855010.Biomet offset tibial tray 71mm; item number#: 141483; lot#: 866560.Offset tib tray neut adaptor; item number#: 141489; lot#: 146410.Bmt splined knee stm v2 20x80; item number#:148310; lot#: 102900.Unknown bearing item number#: unknown; lot#: unknown.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 histories identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combinations.Medical records and radiographs were provided and reviewed by a health care professional.The review of the first revision notes that took place identified no contributing factors to the event.The stability and range of motion were achieved with definitive implants.2 weeks follow-up visit notes states an improvement in pain and an increased activity level.Incision healed nicely without sign of infection.Excellent overall alignment and stability.There was no evidence of early subsidence, loosening, fracture or implant complication.3 months post-op, patient has a feeling of a vice around her knee.It was not possible to determine if it was inflammation or scar tissue.A cortisone shot was offered, and celebrex has been prescribed.Patient reported flexion movements quite painful to force greater rom.No fall or trauma were reported.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.
Event or Problem Description
It was reported that a patient is experiencing pain and ambulation difficulties approximately two years and two and a half months post implantation.At follow-up visit a cortisone shot was offered and celebrex has been prescribed.Attempts to obtain additional information have been made; however, no more information is available.

• 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: 23725888
• Report Number: 3006946279-2025-00127
• Device Sequence Number: 10720929
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)240831(10)I0605Y37BA
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 110035368
• Device Lot Number: I0605Y37BA
• 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: 02/03/2025
• Initial 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 81 KG