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

Model Number SC3349-36-5456

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

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

Event Date 02/20/2015

Event Type  No Answer Provided  

Event Description

Upon receipt and review of the patient implant form, the sales representative noticed that the liner/femoral head combination did not match.From the information received, it was established that a size 32mm femoral head was implanted with a size 36mm acetabular liner.

Manufacturer Narrative

This event is not device related.The device labeling clearly identifies the device size.The circulating nurse and the surgeon erred in choosing the wrong size device.No death, serious injury, or device malfunction occurred.Device not returned to manufacturer.

• Brand Name: EXP ACETABULAR SHELL AND LINER
• Type of Device: 36MM ID, XLPE 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: 4649436
• MDR Text Key: 5758990
• Report Number: 2530191-2015-00007
• 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: Other
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: SC3349-36-5456
• Device Catalogue Number: SC3349-36-5456
• Device Lot Number: 31026-021314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• 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
• Patient Age: 65 YR