MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 8 8MM; KNEE FEMORAL ACCESSORY

Model Number	1547-08-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The patient was revised to address instability.Patient had a rt tka revision on (b)(6) 2019, and then had another revision with poly change on (b)(6) 2019 exchanging a ps rp insert for a crs insert (mdr case number (b)(4)).The surgeon wanted to remove the size 8 crs femur and put in either a size 9 or 10 to lose the flexion gap.The surgeon removed the femoral component.The femoral sleeve and stem stayed in the femur.The surgeon then trialed using a size 9 and 10 femur to close the flexion gap.The surgeon felt that the size 10 femur would be the best option.Implants were open along with augments.The surgeon cemented the femoral component in place and felt like a size 10 crs 20mm insert gave the best stability in extension and flexion.No surgical delay.Doi: (b)(6) 2019, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes 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.

• Brand Name: ATTUNE DIST FEM AUG SZ 8 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10206841
• Report Number: 1818910-2020-14588
• Device Sequence Number: 16951984
• Product Code: JWH
• UDI-Device Identifier: 10603295382867
• UDI-Public: 10603295382867
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 1547-08-002
• Device Catalogue Number: 154708002
• Device Lot Number: J3548Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 20MM; ATTUNE POS FEM AUG SZ 8 12MM; ATTUNE POS FEM AUG SZ 8 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR