MAUDE Adverse Event Report: STELKAST INC. PROFORM HIP SYSTEM; 6.5MM CANCELLOUS BONE

Model Number SC2677-35

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.There is no evidence that a device malfunction was the cause of this incident.

Event Description

Patient presented for right hip surgery.During surgery, the surgeon had difficulty seating the acetabular liner into the acetabular shell.The surgeon removed the shell, re-reamed and implanted the same shell with another screw.The same liner then was seated successfully.

• Brand Name: PROFORM HIP SYSTEM
• Type of Device: 6.5MM CANCELLOUS BONE
• 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: 7432528
• MDR Text Key: 105534555
• Report Number: 2530191-2018-00041
• 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: 01/16/2018

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: Medical Equipment Company Technician/Representative
• Device Model Number: SC2677-35
• Device Lot Number: 39603270515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 54 YR