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

Model Number SC1151-28MM-3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Osteolysis (2377)

Event Date 12/04/2015

Event Type  No Answer Provided  

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

Patient presented for revision surgery because of osteolysis in the area of the acetabular shell in the left hip.Acetabular shell and liner were explanted and revised with competitor devices.28mm femoral head revised with 36mm head.

• 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: anthony lewandowski ; 200 hidden valley road; mcmurray, PA 15317 ; 7249416368
• MDR Report Key: 5341822
• MDR Text Key: 34980164
• Report Number: 2530191-2016-00004
• 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: 01/04/2016

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 Model Number: SC1151-28MM-3
• Device Lot Number: 1788-032197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR