MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM16X60MM; KNEE STEMS

Model Number 1513-16-060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erythema (1840); Unspecified Infection (1930); Pain (1994)

Event Date 05/04/2022

Event Type  Injury  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the medical records from (b)(6) 2022 noted that the patient had a left total knee revision completed on (b)(6) 2022.After the revision, the patient had erythema over the incision and a stitch abscess was cut out.Patient reports having pain due to the superficial infection".Note: the patella was left in situ during (b)(6) 2022 revision.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATUNE PRESSFIT STR STEM16X60MM
• Type of Device: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15257778
• MDR Text Key: 298204874
• Report Number: 1818910-2022-16150
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295043669
• UDI-Public: 10603295043669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1513-16-060
• Device Catalogue Number: 151316060
• Device Lot Number: D21101859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL LT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 8MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 8MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 45MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 6 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR