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

Catalog Number	151101105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
Because the patient had extremely thin femoral cortices prof (b)(6) cemented the tibial component in separately to the femoral component.The tibial cementation went well.However, when prof (b)(6) implanted the definitive femoral component with 50mm femoral sleeve the femur fractured.The surgeon removed the femoral component before the cement had cured and upon inspection of the fracture deemed it necessary to convert to a lps distal femoral component which he had on standby for this surgery.Unfortunately the attune revision rp tibial component was extremely well fixed and as the surgery had already taken over 3 hours the surgeon felt it unwise to continue with a time consuming extraction of the well fixed tibial component.He therefore had no option but to use an incompatible lps insert with the lps femur and attune revision rp tibia.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUN FEM SLV M/L 45MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8655624
• Report Number: 1818910-2019-94844
• Device Sequence Number: 19408018
• Product Code: JWH
• UDI-Device Identifier: 10603295436522
• UDI-Public: 10603295436522
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K063686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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 Catalogue Number: 151101105
• Device Lot Number: HX4983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR