MAUDE Adverse Event Report: DEPUY ORTHOPAEDIDEPUY ORTHOPAEDICS, INC. 1CS, INC. UNKNOWN GLENOSPHERE; SHOULDER HEAD/GLENOSPHERE

Catalog Number UNK-EXTREM

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address shoulder pain.It was reported that the surgeon did and exploration and realized that the glenosphere was semi loose on the metaglene.The surgeon checked and retighten the glenosphere and was satisfied with it being seated completely.He then finished with a poly exchange of the same size that was removed.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN GLENOSPHERE
• Type of Device: SHOULDER HEAD/GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDIDEPUY ORTHOPAEDICS, INC. 1CS, INC.; 700 orthopaedic drive; bp 256; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; bp 256; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6785666
• MDR Text Key: 82399300
• Report Number: 1818910-2017-22599
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-EXTREM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR