MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400109
Medical Device Problem Codes	Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2017, the patient underwent total left knee arthroplasty due to arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and depuy bone cement x 3.On (b)(6) 2018, the patient underwent a left knee revision due to loosening of the tibial component, instability, crepitus/clunk, and pain.The surgeon reported the tibial component was removed with minimal effort and was completely de-bonded from the cement mantle.He noted the femoral component was removed with modest effort and minimal bone loss.The surgeon indicated the patella was revised in the procedure.The patient was implanted with a competitor system and depuy bone cement x 3.There were no complications to the procedure.Doi: (b)(6) 2017; dor: (b)(6) 2018 (lt knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with the reported event was not returned to the investigation site for evaluation.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FEM LT SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9338053
• Report Number: 1818910-2019-116765
• Device Sequence Number: 11330844
• Product Code: JWH
• UDI-Device Identifier: 10603295041108
• UDI-Public: 10603295041108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150400109
• Device Lot Number: 8423064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 69 YR