MAUDE Adverse Event Report: STELKAST INC. PROFORM HIP SYSTEM; 28MM NON-HOODED LINER

Model Number SC1163-5860

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/14/2016

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

Femoral head and acetabular liner revised because of wear.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: 28MM NON-HOODED LINER
• 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: 6190462
• MDR Text Key: 62906069
• Report Number: 2530191-2016-00165
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934162
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC1163-5860
• Device Lot Number: 2170-071998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/1998
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR