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

Model Number SC3349-36-5860

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 01/25/2017

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

Surgeon had difficulty seating the acetabular liner into the acetabular shell.Another liner was used and seated successfully.Doctor unsure if tissue prevented seating of the first liner.

• Brand Name: EXP ACETABULAR SHELL AND LINER
• Type of Device: 36MM 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: 6294104
• MDR Text Key: 66276664
• Report Number: 2530191-2017-00022
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: SC3349-36-5860
• Device Lot Number: 34153200719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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): Required Intervention
• Patient Age: 58 YR