MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT: SCREW

Catalog Number 121725500

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Not Applicable (3189); No Information (3190)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Patient was revised to address cup loosening and migration.

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

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.(b)(4).

Event Description

Update rec'd (b)(6) 2014 - pfs and medical records received.A correct doi was provided.After review of the medical records for mdr reportability, the revision operative note indicated a loose cup.There was no mention of cup migration.There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

Update rec'd 6/20/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain.We are adding the head and liner to address the general litigation allegations of metal on metal.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

The devices associated with this report were not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot codes required were not provided.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 at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.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.Medical records were obtained and reviewed by a medical professional.With the information provided it cannot be determined that the complaint is product related.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

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

Manufacturer Narrative

(b)(4).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

(b)(4).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: SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 3753069
• MDR Text Key: 20291778
• Report Number: 1818910-2014-16965
• 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: 10/08/2014

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: 121725500
• Device Lot Number: Y1XAA4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 04/25/2018; 09/28/2018
• Supplement Dates FDA Received: 07/08/2014; 07/15/2014; 10/30/2014; 02/13/2015; 05/21/2018; 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 102