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

Model Number SC3349-36-5860

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

After implanting the acetabular shell, the surgeon did not use a trial liner but implanted the acetabular liner.The hip was then trial reduced with the femoral broach and trial neck.Upon dislocating the hip to remove the broach and trial neck the liner disassociated from the shell.A new liner was then implanted in the shell.The femoral stem and head were implanted and the surgery proceeded without incident.

Manufacturer Narrative

Review of the device history records shows no anomalies or deficiencies in the manufacturing process.Device was not returned for evaluation.Device not returned.

• Brand Name: EXP ACETABULAR SHELL AND LINER
• Type of Device: 36MM ID 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: 4908658
• MDR Text Key: 6026936
• Report Number: 2530191-2015-00017
• Device Sequence Number: 1
• Product Code: LWJ
• 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: Other
• Type of Report: Initial
• Report Date: 07/13/2015

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: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: SC3349-36-5860
• Device Catalogue Number: SC3349-36-5860
• Device Lot Number: 31916-081814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2014
• 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