MAUDE Adverse Event Report: STELKAST INC. EXP ACETABULAR SHELL AND LINER; 36MM COCR FEMORAL HEAD

Model Number SC3261-36MM -3.5

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 01/13/2017

Event Type  Injury  

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 surgery due to fractured femur.Thirty six millimeter (36mm) femoral head was revised during the surgery.

• Brand Name: EXP ACETABULAR SHELL AND LINER
• Type of Device: 36MM COCR 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: 6264507
• MDR Text Key: 65297251
• Report Number: 2530191-2017-00016
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094035
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SC3261-36MM -3.5
• Device Lot Number: 34803251031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• 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: 80 YR