MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CMK21 STEM-CEMENTED,SIZE 4S1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/06/2005

Event Type  Injury  

Manufacturer Narrative

Information which was obtained approximately 6 years after the event.Patient is part of (b)(6) study.

Event Description

It was reported that patient was treated with medication / orthotics due to leg length difference 0,5 cm, study leg (left) being longer.Outcome of complication: still ongoing.

• Brand Name: CMK21 STEM-CEMENTED,SIZE 4S1
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6325160
• MDR Text Key: 67208267
• Report Number: 1020279-2017-00098
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/23/2017; 06/16/2017
• 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
• Treatment: BIOLOX HEAD-NECK LENGTH S/+0,SIZE 28,PART&LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82