MAUDE Adverse Event Report: DEPUY ORTHOPEDICS HIP IMPLANT

Model Number 122136454

Device Problems Implant, removal of (2320); Device Issue (2379)

Patient Problems Failure of Implant (1924); Surgical procedure, repeated (2042); Joint Dislocation (2374)

Event Date 02/09/2015

Event Type  Injury  

Event Description

Pt with history of degenerative arthritis in both hips.On (b)(6) 2005 left total hip arthroplasty.On (b)(6) 2014 total hip revision, left (14 years after initial replacement; atlr in the setting of a metal on metal arthroplasty).On (b)(6) 2014 left hip prosthetic dislocation-closed reduction.On (b)(6) 2014 left hip prosthetic dislocation-closed reduction.On (b)(6) 2015 left hip prosthetic dislocation-closed reduction.On (b)(6) 2015 total hip revision, left for broke prosthetic joint implant (7 months after first revision).Mfr ref #1818910-2015-15505.

• Brand Name: HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPEDICS; warsaw IN
• MDR Report Key: 4586125
• MDR Text Key: 5479550
• Report Number: 4586125
• Device Sequence Number: 1
• Product Code: KWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 122136454
• Device Catalogue Number: 136536730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 84