MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM; HIP OTHER IMPLANT

Catalog Number 121735500

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address an infection.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

The patient was revised to address an infection.

• Brand Name: PINN CAN BONE SCREW 6.5MMX35MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46582
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 6490954
• MDR Text Key: 72743760
• Report Number: 1818910-2017-16471
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

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: 121735500
• Device Lot Number: D16010557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• 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: 61 YR