MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC SIGMA HP TROCHLEA SZ2 RT; KNEE OTHER IMPLANT

Catalog Number 102404200

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address infection and loosening.The loosening interface and cement manufacturer are unknown.

• Brand Name: SIGMA HP TROCHLEA SZ2 RT
• Type of Device: KNEE OTHER IMPLANT
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5337707
• MDR Text Key: 34735425
• Report Number: 1818910-2015-38229
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102404200
• Device Lot Number: 648607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• 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: 38 YR