MAUDE Adverse Event Report: STELKAST INC. EXP ACETABULAR SHELL AND LINER; 32MM ID XLPE HOODED LIUNER

Model Number SC3345-32-5052

Device Problem Material Fragmentation (1261)

Patient Problem Joint Dislocation (2374)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stelkast was made aware of a revision surgery that required re-implantation of a replacement prosthetic hip.

• Brand Name: EXP ACETABULAR SHELL AND LINER
• Type of Device: 32MM ID XLPE HOODED LIUNER
• 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: 8264276
• MDR Text Key: 133686672
• Report Number: 2530191-2019-00002
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2019
• Device Model Number: SC3345-32-5052
• Device Lot Number: 30925-012714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• 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 Outcome(s): Required Intervention