MAUDE Adverse Event Report: STELKAST INC. PROFORM HIP SYSTEM; 28MM FEMORAL HEAD

Model Number SC1151-28MM-3.5

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Missing Value Reason (3192)

Event Date 12/04/2015

Event Type  No Answer Provided  

Manufacturer Narrative

An analysis 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 hip liner wear.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: 28MM FEMORAL HEAD
• 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: 5377661
• MDR Text Key: 36327132
• Report Number: 2530191-2016-00021
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2011
• Device Model Number: SC1151-28MM-3.5
• Device Lot Number: 4496-090501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2001
• 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: 64 YR