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); Synovitis (2094); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient has continuing pain, swelling, synovitis and difficulty ambulating six years, five months post implantation.Patient received topical lidocaine patches as treatment.An arthroscopic procedure was completed five years post implantation however symptoms persisted.No additional information provided by patient at this time.
Additional Manufacturer Narrative
(b)(4).D-10: (b)(6), 12mm diameter 100mm length straight stem extension combined length 145mm, lot# 63687921.(b)(6), nexgen distal femoral augment block, lot#: 63661850, (b)(6), nexgen all poly patella std cemented size 32mm dia 8.5m, m thick, lot#: 64107592, (b)(6), nexgen 14mm dia 100mm l offset stem extension, lot#: 63810697, (b)(6), nexgen left size e cemented option femoral component, lot#: 63939477, (b)(6), nexgen 12mm h size e, f w/locking screw green articular surface, lot#: 63564388, (b)(6), nexgen size 5 precoat stemmed a/p wedged tibial component, lot#: 63814253.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Based on the available information, the reported event cannot be confirmed.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
No further event information available at the time of this report.

• 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: 21618260
• Report Number: 3006946279-2025-00028
• Device Sequence Number: 6827786
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)221031(10)745DAI1807
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 10/31/2022
• Device Catalogue Number: 110035368
• Device Lot Number: 745DAI1807
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2018
• 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 Sex: Female