MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 6 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).Initial reporter occupation: lawyer.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
Update: medical records received on ad 21 aug 2020 were reviewed on ad 01 sep 2020 by a clinician to identify patient harms/product issues.Patient received a left primary attune to treat premature osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a left knee revision to treat pain and instability secondary to loosening of the tibial tray.Upon entering the joint, the surgeon identified and excised synovitis and swelling.The tibial tray was loosened and debonded at the cement to implant interface and removed.The femoral component was well-fixed but revised.The surgeon notes there was aori type 2a bone loss of the femur and tibia requiring reconstruction.The patella was well-fixed and retained.There was no reported product problem with the explanted tibial insert.The patient was revised with a competitor construct utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2015.Dor: (b)(6) 202.Left 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 CR FEM LT SZ 6 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10535749
• Report Number: 1818910-2020-20078
• Device Sequence Number: 2803019
• Product Code: JWH
• UDI-Device Identifier: 10603295041153
• UDI-Public: 10603295041153
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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 Expiration Date: 09/30/2025
• Device Model Number: 1504-00-126
• Device Catalogue Number: 150400126
• Device Lot Number: 699112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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 CR FEM LT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 7MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; ATTUNE CR FEM LT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 7MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR