MAUDE Adverse Event Report: STELKAST INC. EXP ACETABULAR SHELL AND LINER; 36MM NON-HOODED LINER

Model Number SC3260-36-5456

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During hip surgery, the acetabular liner would not seat properly into the shell.A second liner was implanted successfully.

• Brand Name: EXP ACETABULAR SHELL AND LINER
• Type of Device: 36MM NON-HOODED 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: 7306516
• MDR Text Key: 101359287
• Report Number: 2530191-2018-00026
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2020
• Device Model Number: SC3260-36-5456
• Device Lot Number: 37193220226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2017
• 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): Required Intervention
• Patient Age: 80 YR