MAUDE Adverse Event Report: ARTHROSURFACE HIP HEMICAP; HIP JOINT FEMORAL (HEMI-HIP) METALLIC RESURFACING PROSTHESIS.

Model Number 6302-0050/ 6125-0035

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/31/2005

Event Type  No Answer Provided  

Manufacturer Narrative

Conversation with surgeon revealed that patient began activities (playing tennis) prior to recommended recovery time.Larger size hip hemicap implant was placed in the patient.No further follow-up information is available at this time.

Event Description

Patient reported pain following hip hemicap implant procedure.

• Brand Name: HIP HEMICAP
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METALLIC RESURFACING PROSTHESIS.
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5225337
• MDR Text Key: 31250200
• Report Number: 3004154314-2006-00001
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K021549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6302-0050/ 6125-0035
• Device Catalogue Number: 6302-0050/ 6125-0035
• Device Lot Number: 63CD3102/ 63ED1110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Outcome(s): Required Intervention