MAUDE Adverse Event Report: DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 SIGMA HP UNI FEMORAL SZ5 RM/LL; KNEE FEMORAL COMPONENT

Catalog Number 102408500

Device Problems Loss of Osseointegration (2408); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Swelling (2356)

Event Date 07/15/2013

Event Type  Injury  

Event Description

The patient called in stating they were having problem with their right knee.They were experiencing pain, clicking, and swelling.Records indicate upon redivision the patient's 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 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: 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

Update rec¿d (b)(6) 2014 and (b)(6) 2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.The product part/lot's are being updated, and the cement is being added to the complaint and reported at this time.The device associated with this report was not returned.A complaint database search finds no other reported incidents against the provided product and lot combination.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.Received patient medical records were reviewed by a depuy medical professional.With the information provided, it cannot be determined that the complaint is product related.The loose components were likely the cause of the patient¿s pain.The investigation could not verify or identify any product contribution to the reported event with the information provided.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 the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).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.

Event Description

Update rec 11/17/2014 and 12/09/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.The product part/lot's are being updated, and the cement is being added to the complaint and reported at this time.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The devices associated with this report were not returned.Review of the device history records and/or a complaint database search was not possible as the product and lot codes required were not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Medical records and x-rays photographs were received and attached, however the quality of them is poor and un-readable.Should updated records be received this complaint will be reopened for medical record review.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: SIGMA HP UNI FEMORAL SZ5 RM/LL
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3646479
• MDR Text Key: 4185734
• Report Number: 1818910-2014-13283
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070849
• 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,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102408500
• Device Lot Number: 199791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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: 50 YR
• Patient Weight: 88