MAUDE Adverse Event Report: STELKAST, INC. PROFORM HIP SYSTEM; 28MM I.D. HOODED LINER

Model Number SC1175-5052

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  No Answer Provided  

Event Description

Stelkast was made aware of a lawsuit involving a competitor's device that were used with stelkast devices.A subpoena was received by stelkast on july 1, 2015 and was issued at the request of the competitor's lawyer for information regarding the stelkast proform shell and the 28mm hooded acetabular liner.No other information was received regarding any incident related to stelkast devices.If any new information becomes available, this report will be amended.

Manufacturer Narrative

Device not returned.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: 28MM I.D. 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: 4909582
• MDR Text Key: 6833502
• Report Number: 2530191-2015-00019
• 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: Other
• Type of Report: Initial
• Report Date: 07/13/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: SC1175-5052
• Device Catalogue Number: SC1175-5052
• Device Lot Number: 7034-101303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2003
• 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