MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 45MM FULL POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed secondary to thigh pain.No evidence of infection or loosening.Surgeon suspected the pain may be being generated from a large femoral press fit stem.After discussions with the patient, the decision was made to do a femoral only revision - plan a being to revise the femoral sleeve to a larger size and reduce the femoral stem diameter.Plan b would be either an s-rom hinge or lps distal femoral replacement depending on bone quality following removal of the current attune revision femoral components.The removal process was not simple as the initial components were well fixed, and as a result there was a complete fracture of the lateral distal femoral condyle as well as significant metaphyseal bone loss of the distal femur whilst attempting to remove the well fixed sleeve and stem.Palacos bone cement was used in all procedures.Plan b was actioned and a lps distal femoral replacement was performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received indicated that there was no surgical delay reported and the affected side involved in this event was the right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available photo evidence were reviewed and does not shows an implant fracture, disassociation or any indicative related to a device nonconformance.Based on the information provided, a defect or malfunction cannot be established, therefore the allegation is not confirmed.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: ATUN FEM SLV M/L 45MM FULL POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14886472
• Report Number: 1818910-2022-12218
• Device Sequence Number: 6283434
• Product Code: JWH
• UDI-Device Identifier: 10603295419594
• UDI-Public: 10603295419594
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: Health Professional
• Device Model Number: 1511-01-205
• Device Catalogue Number: 151101205
• Device Lot Number: J14R17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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: ATTUNE CRS FEMORAL RT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 8MM; ATUNE PRESSFIT STR STEM18X60MM; PALACOS BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male