MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121720500

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

Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Necrosis (1971); Scar Tissue (2060); No Code Available (3191)

Event Date 04/20/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.Patient revised for a pseudo-tumor possibly from metal hypersensitivity, removed cup for highly inclined placement.Doi: (b)(6) 2007.Dor: (b)(6) 2010.(right hip).Update.12/21/2010.Litigation papers were received.1/12/2011 screw inadvertently reported.File reopened to change to liner.Update: 10/19/2012 pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.Update ad 1 nov 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf, sticker sheets and medical record.In addition to what were previously alleged, ppf alleges loosening of cup, fracture, dislocation, infection, loosening of stem, metal wear, metallosis and elevated metal ions.Please see: (b)(4).(revision).Doi: (b)(6) 2007.Dor: (b)(6) 2010.(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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX20MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9078350
• MDR Text Key: 162971941
• Report Number: 1818910-2019-104990
• Device Sequence Number: 1
• Product Code: NDJ
• UDI-Device Identifier: 10603295009795
• UDI-Public: 10603295009795
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2010

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: 09/30/2017
• Device Catalogue Number: 121720500
• Device Lot Number: B4ABM4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2007
• 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: 63 YR
• Patient Weight: 104