MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK KNEE FEMORAL ATTUNE REVISION; FEMORAL

Catalog Number UNK KNEE FEMORAL ATTUNE REVISI

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

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Pc was created to capture the event: (b)(4) medical records ad (b)(6) 2022 (2) these records contain a series of clinic visits with a pain management physician.The notes detail patient¿s ongoing back and knee pain and antalgic gait prior to and after the left knee revision that occurred on (b)(6) 2019.(b)(6) 2018: a genicular nerve block was attempted but there was ¿bone in the way¿ and the nerve could not be accessed.Pain continued to be managed by oral pain medication.

Manufacturer Narrative

Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi # is unavailable.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.

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 a manufacturing records evaluation (mre) was not performed as no lot number or product code was provided for this device.

• Brand Name: UNK KNEE FEMORAL ATTUNE REVISION
• Type of Device: FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15840654
• MDR Text Key: 304086984
• Report Number: 1818910-2022-23419
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL ATTUNE REVISI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SIZE 8; SIZE 7 MBT WITH A 45 MM METAPHYSEAL SLEEVE; SIZE 8,6MM MOBILE-BEARING
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male