MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM10X110MM; KNEE STEMS

Model Number	1513-10-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thromboembolism (2654); No Code Available (3191)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On (b)(6) 2018 the patient was revised to address loosening of right tibial component, pain, subsidence of tibial tray, varus contracture of leg, and synovitis.On (b)(6) 2018 patient had an i and d for necrotic wound posterior medial aspect of right knee.The patient had been on oral antibiotics prior to procedure.On (b)(6) 2019 the patient had a revision of right total knee arthroplasty with revision of both tibial and femoral components along with a right popliteal artery thrombectomy with femoral popliteal bypass due to loose total knee arthroplasty, right knee with popliteal artery thrombus and pain.Doi: (b)(6) 2016 (patellar and femoral component); doi: (b)(6) 2018 (tibial tray, insert, stem, augment and bone cement); dor: (b)(6) 2019 (rt knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.  h10 additional narrative: udi: (b)(4).Added: h6 (patient).
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.  no code available (3191) was used to capture device revision or replacement.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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: ATUN PRESSFIT STR STEM10X110MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9566150
• Report Number: 1818910-2020-01177
• Device Sequence Number: 11523846
• Product Code: JWH
• UDI-Device Identifier: 10603295043492
• UDI-Public: 10603295043492
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2020

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: 1513-10-110
• Device Catalogue Number: 151310110
• Device Lot Number: H71951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 02/12/2020; 03/20/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/15/2020; 02/14/2020; 03/31/2020
• 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 MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 12MM; ATUN TIB AUG RM/LL SZ 3/4 10MM; ATUNE REV RP TIB BASE SZ 4 CEM; DEPUY1 GENTAMICIN CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 64