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

Model Number SC3261-36MM +7

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 07/02/2015

Event Type  No Answer Provided  

Event Description

Patient dislocated in recovery.The surgeon's opinion is that he did not allow for enough anteversion - corrected with hooded liner.The original stem, head and liner were also replaced.

Manufacturer Narrative

A review of the device history record for this device shows that no material property, mechanical, or dimensional discrepancies existed in this lot.Device not returned.

• 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: 4954291
• MDR Text Key: 16227325
• Report Number: 2530191-2015-00021
• Device Sequence Number: 1
• Product Code: OQI
• 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: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: SC3261-36MM +7
• Device Catalogue Number: SC3261-36MM +7
• Device Lot Number: 26414-070611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2011
• 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: 67 YR