MAUDE Adverse Event Report: STELKAST, INC. PROVIDENT HIP SYSTEM; PROVIDENT STEM

Model Number SC2658-13.75

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/02/2015

Event Type  No Answer Provided  

Event Description

Patient dislocated in recovery.The surgeon's opinion is that he did not allow for enough anteversion - corrected with hooded liner.The original stem, head and liner were also replaced.

Manufacturer Narrative

A review of the device history record for this device show that there were no material property, mechanical, or dimensional discrepancies existed in this lot.Device not returned.

• Brand Name: PROVIDENT HIP SYSTEM
• Type of Device: PROVIDENT STEM
• Manufacturer (Section D): STELKAST, INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer (Section G): STELKAST, INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer Contact: john reyher ; 200 hidden valley road; mcmurray, PA 15317 ; 7249416368
• MDR Report Key: 4953968
• MDR Text Key: 20808974
• Report Number: 2530191-2015-00020
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/30/2015

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 Model Number: SC2658-13.75
• Device Catalogue Number: SC2658-13.75
• Device Lot Number: 31686-091514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2014
• 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: 67 YR