MAUDE Adverse Event Report: DEPUY INTL.,LTD 8010379 UNIDENTIFIED 4.5 NON LOCKING SCREWS; SHOULDER OTHER IMPLANT

Catalog Number UNK-EXTREM

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 04/04/2017

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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Patient was revised due to metaglene loosening.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed.Should 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: UNIDENTIFIED 4.5 NON LOCKING SCREWS
• Type of Device: SHOULDER OTHER IMPLANT
• Manufacturer (Section D): DEPUY INTL.,LTD 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL.,LTD 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6523200
• MDR Text Key: 73746544
• Report Number: 1818910-2017-17068
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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: 05/31/2017
• 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): Required Intervention
• Patient Age: 59 YR