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

Model Number SC1163-5456

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/06/2015

Event Type  No Answer Provided  

Manufacturer Narrative

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

Event Description

Patient was presented for surgery after it was radiographically determined that the hip stem became loose in the medial/proximal region.A competitor's stem was used along with their femoral head.Liner was revised from 28mm to 36mm.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: 28 MM HOODED ID 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: 5198415
• MDR Text Key: 30282378
• Report Number: 2530191-2015-00045
• 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: 11/03/2015

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: No Information
• Device Model Number: SC1163-5456
• Device Catalogue Number: SC1163-5456
• Device Lot Number: 7031-080703
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2003
• 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
• Patient Age: 84 YR