MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. LCS ROT PATELLA STD; KNEE PATELLAR COMPONENT

Catalog Number 117967000

Device Problems Fracture (1260); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Patient was revised due to a patella that "broke in half", osteolysis, and poly wear (patella).It is unknown how the fracture occurred.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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

Manufacturer Narrative

The devices associated with this report were not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.Patient medicala records were provided.Review of the supplied medical records confirmed fracture of the patella device.The reported metallosis was not confirmed.The investigation could not draw any conclusions about the root cause of the reported event based on the provided information.Provided information stated the patient presented with a broken patellar polyethylene component.He noted that the metal backing of the previously placed patellar component had been rubbing and he felt this caused the metallosis.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.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS ROT PATELLA STD
• Type of Device: KNEE PATELLAR 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: 3929025
• MDR Text Key: 4537047
• Report Number: 1818910-2014-23219
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• 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,Followup,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 117967000
• Device Lot Number: 992950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/1994
• 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: 63 YR
• Patient Weight: 74