MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT REV SLV LPS FEM ADP +10; KNEE FEMORAL ADAPTOR

Catalog Number 151106010

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 07/12/2023

Event Type  Injury  

Event Description

It was reported that the patient present in office with thigh pain.Serial x-rays show lucency around stem and subsidence of sleeve leading surgeon to believe that the stem sleeve did not achieve stable ingrowth.Sleeve is found to have only achieved fibrous ingrowth and is removed.A cemented bowed stem is placed uneventfully after clearing fibrous tissue.No patient harm occurred.No surgical delay.Doi: (b)(6), 2022.Dor: (b)(6), 2023.Affected side: right knee.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

• Brand Name: ATT REV SLV LPS FEM ADP +10
• Type of Device: KNEE FEMORAL ADAPTOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17391107
• MDR Text Key: 319758753
• Report Number: 1818910-2023-15148
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295503415
• UDI-Public: 10603295503415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151106010
• Device Lot Number: JF3696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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 REV LPS INSRT XXSM 16MM; ATUN FEM SLV M/L 35MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM RT
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 53 KG