MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM10X60MM; KNEE STEMS

Catalog Number	151310060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2018
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
Clinical adverse event received for wound healing delay.Event is not serious and is considered mild.Event is definitely not related to device and is there is a remote possibility it is related to procedure.Date of implantation: (b)(6) 2018; date of event: (b)(6) 2018; (right 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.A worldwide complaint database search did find other reported incident(s) against the provided product/lot combination(s) but they were all from the same clinical study and none were found to be related to a product defect.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUNE PRESSFIT STR STEM10X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9218900
• Report Number: 1818910-2019-110639
• Device Sequence Number: 16700190
• Product Code: JWH
• UDI-Device Identifier: 10603295043485
• UDI-Public: 10603295043485
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151310060
• Device Lot Number: HP7101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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: UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 115