MAUDE Adverse Event Report: DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965 SIGMA HP UNI FEMORAL SZ4 RM/LL; KNEE FEMORAL COMPONENT

Catalog Number 102408400

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/09/2014

Event Type  Injury  

Event Description

Patient was revised to address pain.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.(b)(4).Depuy synthes has been informed that the catalog number and lot number is not available.

• Brand Name: SIGMA HP UNI FEMORAL SZ4 RM/LL
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4362798
• MDR Text Key: 5264105
• Report Number: 1818910-2014-35139
• Device Sequence Number: 1
• Product Code: HRY
• 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
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 102408400
• Device Lot Number: 405575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2013
• 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 Weight: 122