MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121735500

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

Patient Problems Cardiac Arrest (1762); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

(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 litigation records received.Litigation alleges that corrosion and friction wear had caused metal ion and particles to be released into the patient¿s blood and tissues and bone surrounding the implant resulting to injuries such as adverse local tissue reaction, pain, crunching or popping noises in the hips, standing and walking difficulties, hip fractures or dislocations, fatigue, tissue inflammation, necrosis, metallosis, limited mobility, and tissue and bone damage.The patient is also suffering from discomfort, emotional distress and other injuries caused by the failed hip implant.Doi: (b)(6) 2007; dor: (b)(6) 2017; left hip.Patient is bilateral, see (b)(4) for the right hip.

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.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).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.  .

Event Description

Ppf alleges infection, heart attack and loose stem.

• Brand Name: PINN CAN BONE SCREW 6.5MMX35MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8773328
• MDR Text Key: 150523283
• Report Number: 1818910-2019-97878
• Device Sequence Number: 1
• Product Code: NDJ
• UDI-Device Identifier: 10603295010388
• UDI-Public: 10603295010388
• Combination Product (y/n): N
• PMA/PMN Number: NDJ/K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121735500
• Device Lot Number: B28E64000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR