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

Catalog Number	110034355
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: refobacin bc r 1x40 us; item# 110034355; lot# 849abh1703.Refobacin bc r 1x40 us; item# 110034355; lot# 849abh1703.Refobacin bc r 1x40 us; item# 110034355; lot# 839haa0807.Femur cemented plus left size 9+; item# 42504606611; lot# 64288155.Stem extension 6mm offset splined uncemented 17 mm diameter +135 mm length; item# 42560613517; lot# 64542501.Femoral central cone size small; item# 42545001011; lot# 64470408.Femoral distal augment cemented size 9, 9+ 5 mm thickness; item# 42556606605; lot# 64345779, tibia fixed cemented left size f stem extension use required; item# 42542007501; lot# 64334587, articular surface fixed bearing constrained condylar knee (cck) left 12 mm height use with tibia sizes e, f / revision femur sizes 7, 7+, 9, 9+ with l; item# 42512800712; lot# 64305404, stem extension 6mm offset splined uncemented 15 mm diameter +135 mm length; item# 42560613515; lot# 64523137.Tibial central cone size x-small; item# 42545000510; lot# 64470026, tibial augment cemented half block left lateral size ef 10 mm thickness; item# 42555805110; lot# 64453282, tibial augment cemented half block left medial size ef 10 mm thickness; item# 42555805310; lot# 64352568.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 experienced pes bursitis, pain, throbbing, cramping and tightness approximately four (4) years following left knee arthroplasty.The patient was prescribed meloxicam and given a cortisone injection as well as topical pain therapies.Initial operative notes noted the patient's tibial bone was quite sclerotic from an unknown previous procedure and several small drill holes were made to help with cement interdigitation; however, no intraoperative complications were noted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.The products remain implanted; therefore, visual 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 lot 849abh1703.Review of the complaint histories identified additional similar complaints for the reported lots 839haa0807 and 849bah1404.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records and radiographs were provided and reviewed by a health care professional.The review of the x-ray identified no significant findings; well fixed implants with no lysis loosening or wear, excellent bone cement metal interface.The review of medical records identified moderate occasional pain that requires medication.Obesity, multiple surgeries and prior quadricep were identified as contributing factors to the event.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: REFOBACIN 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20265849
• Report Number: 3006946279-2024-00060
• Device Sequence Number: 8261169
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)211130(10)849BAH1404
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 11/30/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 849BAH1404
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2019
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American