MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FB TIB BASE SZ 6 POR; KNEE IMPLANT - TIBIAL TRAY

Catalog Number	150621006
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
Patient was revised due to loosening of tibial component at the bone to implant interface.Surgeon performed a ltk on this patient the day before the issue arose.This patient had a fracture of his the tibia.Surgeon saw the fracture on the patient's post op x-rays.Surgeon elected to take the patient back to surgery the following day.Surgeon went in and removed the tibial insert and tibial tray.Once the previous implants were removed, the fracture was stable and nondisplaced.Surgeon then choose to use a stemmed tibial component bypassing the fracture site.The new components were cemented into place adding to immediate stability of the component.A new insert was chosen to complete the stability of the knee.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FB TIB BASE SZ 6 POR
• Common Device Name: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20724676
• Report Number: 1818910-2024-24067
• Device Sequence Number: 3850898
• Product Code: MBH
• UDI-Device Identifier: 10603295507451
• UDI-Public: (01)10603295507451
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: Health Professional
• Device Catalogue Number: 150621006
• Device Lot Number: JA06A1509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ATTUNE CR FB INSRT SZ 5 6MM.; UNKNOWN BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male