MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE CALCAR SZ3 145MM; MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

Catalog Number 152161000

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/13/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: articuleze m head 36mm +12, 136554000.

Event Description

Ppf and implant record received.Ppf alleges loosening of stem and bone fracture.Doi: (b)(6) 2006; dor: (b)(6) 2009; (left hip).

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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.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: ENDURANCE CALCAR SZ3 145MM
• Type of Device: MISCELLANEOUS HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7812324
• MDR Text Key: 118096533
• Report Number: 1818910-2018-67572
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 10603295057321
• UDI-Public: 10603295057321
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 152161000
• Device Lot Number: ZV8EB1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2005
• 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: 52 YR