MAUDE Adverse Event Report: STELKAST, INC. PROFORM HIP SYSTEM; ACETABULAR BONE SCREW

Model Number SC2677-35

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  No Answer Provided  

Event Description

Shell and liner implanted.While trialing with broach/trial head, the shell and liner came out.Inserted same shell and liner using a bone screw.Stripped the head on the screw - ruined the liner.Implanted the second liner and a new screw.

Manufacturer Narrative

A review of the device history record for this device shows that there were no material property, mechanical, or dimensional discrepancies with this production lot.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: ACETABULAR BONE SCREW
• 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: 4960116
• MDR Text Key: 6039103
• Report Number: 2530191-2015-00023
• 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: 08/03/2015

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 Expiration Date: 01/01/2022
• Device Model Number: SC2677-35
• Device Catalogue Number: SC2677-35
• Device Lot Number: 26973-012312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2012
• 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: 48 YR