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

Catalog Number 121730500

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969)

Event Date 06/01/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

New unity record created in order to update legacy complaint number: (b)(4).The patient was revised because of poor cup positioning.Doi: 2004 dor: (b)(6) 2009 (right side).Update 09/28/2011 - litigation papers allege patient had left hip explanted on (b)(6) 2009.Doi: (b)(6) 2009.Update 11/26/2012 - medical records were received.Doi was corrected in patient/surgery information of complaint.There is no new information that would change the existing mdr decision.Pfs and sticker sheets are available on external hard drive if needed for further review.Doi: (b)(6) 2009.Update ad 21 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and implant sticker sheet.In addition to what were previously alleged, ppf alleges stroke and heart attack after the first revision.Updated manufacturing date, udi and patient harm.Doi: (b)(6) 2009; dor: (b)(6) 2009; left hip (second revision).(b)(4) - 1st revision (left); (b)(4) - 3rd not revised (left); (b)(4) - 1st revision (right); (b)(4) - 2nd not revised (right).

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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7620489
• MDR Text Key: 111717772
• Report Number: 1818910-2018-62707
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010159
• UDI-Public: 10603295010159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2018
• Device Catalogue Number: 121730500
• Device Lot Number: C5EP74000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/04/2018
• Date Device Manufactured: 06/20/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 82