MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121730500

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

Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771); Death (1802)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Ppf and sticker sheets received.Ppf alleges stroke and heart attack.Ppf noted that the patient is deceased.Doi: (b)(6) 2008 (cup, screw, hole eliminator).Doi: (b)(6) 2012 (liner).Dor: none reported; right hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: null.Device history batch: null.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.

Manufacturer Narrative

Added additional information to the event description.

Event Description

Complaint description: litigation alleges the patient suffers from pain, discomfort and inflammation.Litigation also alleges the patient died due to an ischemic stroke after having unresponsiveness after his surgery.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9075257
• MDR Text Key: 158785764
• Report Number: 1818910-2019-104853
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010159
• UDI-Public: 10603295010159
• Combination Product (y/n): N
• PMA/PMN Number: 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121730500
• Device Lot Number: BT9AV4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 08/26/2019; 09/19/2019
• Supplement Dates FDA Received: 09/17/2019; 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death