MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ARTICULEZE M HEAD 36MM -2; HIP FEMORAL HEAD

Catalog Number 136550000

Device Problem Insufficient Information (3190)

Patient Problems Discomfort (2330); Joint Swelling (2356)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle revision, left hip.Reason for revision: discomfort over greater trochanter and evidence of effusion associated with the left hip prosthesis suspicious for early metal on metal prosthesis complication.

Manufacturer Narrative

No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICULEZE M HEAD 36MM -2
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7074510
• MDR Text Key: 93447670
• Report Number: 1818910-2017-29654
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033899
• UDI-Public: 10603295033899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2015
• Device Catalogue Number: 136550000
• Device Lot Number: 3082744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2010
• 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