MAUDE Adverse Event Report: DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

Catalog Number 121725500

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 10/29/2014

Event Type  Injury  

Event Description

Patient was revised to address metallosis and cup malpositioning.

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

Patient was revised to address metallosis and cup malpositioning.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds one other report against the metal insert lot code.Per procedure, this device is exempt from dhr review.A search of the complaints databases finds no other reports against the remaining product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4275505
• MDR Text Key: 20120605
• Report Number: 1818910-2014-32555
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2019
• Device Catalogue Number: 121725500
• Device Lot Number: DW7CJ4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2009
• 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: 64 YR