MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-080

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

Patient Problems Abscess (1690); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address pain and periprosthetic infection.Aspiration was negative for bacteria but also had 111 white blood cells.Intraoperatively, there was gross pus, bone loss, a deficiency of the posterior column related to the infection and fracture cracks in the proximal femur.Implants were removed and a non-articulating spacer construct of unknown manufacturer was placed.Revision notes on the second revision for removal of said spacer on (b)(6) 2018 indicate presence of a dark murky fluid consistent with metallosis as well as chalky, metallosis type debris.Doi: (b)(6) 2006, dor: (b)(6) 2018 (right hip).

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

• Brand Name: SUMMIT POR TAPER SZ2 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9852875
• MDR Text Key: 184059652
• Report Number: 1818910-2020-08565
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295059332
• UDI-Public: 10603295059332
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1570-01-080
• Device Catalogue Number: 157001080
• Device Lot Number: Y5XEH1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUP 121722050/AA9M91000.; HEAD 136511500/1232621.; LINER 121889150/1865880.; SCREW 121720500/Z12C74000.; CUP 121722050/AA9M91000; HEAD 136511500/1232621; LINER 121889150/1865880; SCREW 121720500/Z12C74000
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR