MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT

Catalog Number 121730500

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/30/2014

Event Type  Injury  

Event Description

Patient was revised to address pain.

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.

Manufacturer Narrative

Additional narrative: update rec'd 7/11/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Dob has been provided.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.

Manufacturer Narrative

Patient was revised to address pain.Update rec'd 7/11/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Dob has been provided.(b)(4).The devices associated with this report were not returned.Per wi-3430, a review of the device history records for the 2549760 lot code is no longer required.A complaint database search finds no other reported incidents against the remaining product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.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

Product complaint # (b)(4).Investigation summary
=
> 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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

Event Description

In addition to what were previously alleged, pfs alleges swelling, immobility and muscle spasm.After review of medical records, it was stated tat the patient was revised due to pain.Revision notes stated synovitis, inflammation and fluid in the joint.

Event Description

Ppf alleges metal wear and metallosis.

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. .

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 3946925
• MDR Text Key: 4646000
• Report Number: 1818910-2014-23846
• 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: Health Professional,Distributor,distributor,health prof
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/30/2014

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 Catalogue Number: 121730500
• Device Lot Number: CB5GM4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 07/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/11/2019; 04/02/2019; 08/22/2019
• Supplement Dates FDA Received: 07/22/2014; 08/13/2014; 03/29/2019; 04/24/2019; 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 81