MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

Catalog Number 121725500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930)

Event Date 03/25/2010

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.-litigation alleges that the patient suffers from ongoing infection.Doi:(b)(6) 2010 - dor: (b)(6) 2010 (right hip).Patient is a resident of (b)(6).Update rec¿d (b)(6 )2014¿ medical records received.Part/lot was provided.After review of the medical records it confirmed the patient was revised on (b)(6) 2010 for retained infection.The unknown depuy hip is being changed to the cup.Eight screws, liner, femoral head, and hole eliminator are being reported for infection.The stem and sleeve were previously reported in (b)(4) for infection.The patient had antibiotic spacers placed (b)(6) 2010.There is no new additional information that would affect the existing mdr decision.The complaint was updated on : (b)(6) 2014.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The devices associated with this report were not returned.A review of the device history records for the b53bg4000 and bc8c74000 lot codes did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other reported incidents against the remaining product and lot combinations.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update rec'd 11/08/2012 - pfs and medical records received.After review of the medical records the patient actually had ongoing infection and the implants were removed on (b)(6) 2010 and spacers placed so the dor needs to be changed to (b)(6) 2010.The spacers were removed and new implants placed on (b)(6) 2010.There is no new additional information that would affect the existing mdr decision.

Event Description

Ppf alleges stroke, heart attack, pulmonary embolism and reported that the patient is deceased, reason and date of death were not provided.

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 3756347
• MDR Text Key: 4552016
• Report Number: 1818910-2014-17068
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2012

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: Physician
• Device Catalogue Number: 121725500
• Device Lot Number: BC8C74000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 04/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/13/2019; 12/19/2019
• Supplement Dates FDA Received: 06/17/2014; 11/13/2014; 06/21/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention