MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX40MM; HIP OTHER IMPLANT

Catalog Number 121740500

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

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 09/03/2013

Event Type  Injury  

Event Description

Litigation alleges that the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Update received: 1/20/2015.The sales rep has reported the revision surgery.Patient was revised to address pain.Complaint was updated on 1/26/2015.

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.(b)(4).

Manufacturer Narrative

Additional narrative: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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

Depuy still considers this investigation closed at this time.

Event Description

Update 6/24/15-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, metal ion levels below 7ppb, and corrosion between the head and stem.The stem is being added to the complaint.

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.

Manufacturer Narrative

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.H10 additional narrative:  udi: (b)(4).Added: b5, h6.

Event Description

Ppf alleges metallosis and elevated metal ion.

• Brand Name: PINN CAN BONE SCREW 6.5MMX40MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4492759
• MDR Text Key: 5328639
• Report Number: 1818910-2015-12932
• 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: 01/20/2015

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: 11/09/2009
• Device Catalogue Number: 121740500
• Device Lot Number: Y5WAX4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 02/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/27/2019; 11/20/2019
• Supplement Dates FDA Received: 03/17/2015; 07/22/2015; 09/12/2019; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 71