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

Model Number SC2658-15.0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient presented for surgery for peri-prosthetic fracture.Hip stem was revised with competitor's.Acetabular liner revised to accommodate 36mm femoral head.

• 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: 5343542
• MDR Text Key: 35036026
• Report Number: 2530191-2016-00006
• 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: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SC2658-15.0
• Device Lot Number: 16986-121206
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2006
• 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 Age: 76 YR