MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY FEMORAL COMPONENT; KNEE FEMORAL COMPONENT

Catalog Number UNK-KNEE

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 01/13/2012

Event Type  Injury  

Event Description

The patient was revised to address aseptic loosening and subsidence of their knee.The medical records indicate the patient's tibial and femoral components were found to be loose.

Manufacturer Narrative

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

Manufacturer Narrative

The device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.Patient medical records were provided.Review of the supplied medical records confirmed device loosening.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided.The investigation could not draw any conclusions about the root cause of the device loosening.With the limited amount of information provided, it cannot be determined that the complaint is product related.Based on the inability to identify root cause, the need for corrective action was not indicated.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.

• Brand Name: UNKNOWN DEPUY FEMORAL COMPONENT
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4102806
• MDR Text Key: 4696258
• Report Number: 1818910-2014-28524
• Device Sequence Number: 1
• Product Code: HSX
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-KNEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• 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 Age: 85 YR
• Patient Weight: 64