MAUDE Adverse Event Report: STELKAST INC. CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM; CROSS OVER SHELL

Model Number SC3458-52

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.

Event Description

Patient presented for hip surgery for unknown reason.During this surgery, the surgeon used a 36mm liner inserter to insert an acetabular liner into the shell.During impaction, it was stated that the liner would not seat properly.While extracting the liner with a hemostat, the surgeon noted that the locking ring detached from the acetabular shell.The locking ring was reinserted and using a 32mm liner inserter he was able to seat the original liner properly.

• Brand Name: CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM
• Type of Device: CROSS OVER SHELL
• 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: 7317834
• MDR Text Key: 101641208
• Report Number: 2530191-2018-00030
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SC3458-52
• Device Lot Number: 38853270409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2017
• 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: 65 YR