MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 GLOBAL SHD END PEG GLEN 44; SHOULDER BEARING

Catalog Number 113785025

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/11/2014

Event Type  Injury  

Event Description

Procedure: revision total shoulder arthroplasty.Primary surgery date (b)(6) 2004.Revision surgery date (b)(6) 2014, performed by (b)(6) at (b)(6).Reason for revision surgery: patient presented to surgeon with pain and a poor functioning shoulder.Surgeon revised a global advantage total shoulder to a delta xtend total shoulder replacement.All of the original implants were removed and discarded as per hospital protocol.(b)(6) 2014 - update: we have received further information for this case to indicate that this patient had a soft tissue failure of the rotator cuff.This lead to the prosthesis riding high and over time lead to the wear on the glenoid component.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The devices associated with this report were not returned.Review of the provided x-rays did not identify any product contribution to the revision surgery.Provided information states the patient had a soft tissue failure of the rotator cuff.This may have leaded the prosthesis riding high and over time to the wear on the glenoid component.A complaint database search finds no other reported incidents against the provided product and lot combinations.Besides receiving the x-rays, the initial reporting stated no additional investigational inputs were available.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: GLOBAL SHD END PEG GLEN 44
• Type of Device: SHOULDER BEARING
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3909441
• MDR Text Key: 4514335
• Report Number: 1818910-2014-22499
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK905786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113785025
• Device Lot Number: XB1DC1029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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