MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM NAR POR CR LT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-01-126
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	10/29/2019
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
Primary attune total knee implanted due to osteoarthritis of the left knee.The patella was resurfaced, and depuy cement x 1 was utilized.There were no surgical or postoperative complications reported.Revision of the left knee due to loosening of the tibial tray.Intraoperatively, the surgeons found loosening of the tibial tray and femoral component at the implant to bone interface as evidenced by fibrous ingrowth and easy removal.The patellar component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The procedure was completed without complications and the patient was revised with depuy components and depuy cement x2.Doi: (b)(6) 2018; dor: (b)(6) 2019; left knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 FEM NAR POR CR LT SZ 6
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9739401
• Report Number: 1818910-2020-05656
• Device Sequence Number: 355445
• Product Code: JWH
• UDI-Device Identifier: 10603295041436
• UDI-Public: 10603295041436
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-01-126
• Device Catalogue Number: 150401126
• Device Lot Number: 8512178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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 RP INSRT SZ 6 8MM; ATTUNE FEM NAR POR CR LT SZ 6; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE RP TIB BASE SZ 5 POR; DEPUY CMW 2 20G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 76