MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 GLOBAL SHD END FIN GLEN 48; SHOULDER BEARING

Catalog Number 113796025

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 10/23/2014

Event Type  Injury  

Event Description

Patient was revised to address loosening of the glenoid.

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.(b)(4).

Manufacturer Narrative

The device associated with this report was not returned.A search of the complaint database found one prior report for loosening; however, review of the as400 system show that other devices from the reported lot have been delivered and/or invoiced and can be reasonably concluded implanted without issue as no further reports are identified.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.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 FIN GLEN 48
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4270444
• MDR Text Key: 5296332
• Report Number: 1818910-2014-32272
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2008
• Device Catalogue Number: 113796025
• Device Lot Number: X74BH1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2003
• 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: 78 YR
• Patient Weight: 77