MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE SF W/HM TECHNOLOGY; HIP COMPONENT

Catalog Number 38HM-1048

Device Problems Bent (1059); Mechanical Problem (1384)

Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 03/25/2015

Event Type  Injury  

Event Description

Allegedly, patient revised due to pain, difficulty walking, sitting, bending.Popping, grinding, walks with a limp, elevated cobalt and chromium levels.Right.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: CONSERVE SF W/HM TECHNOLOGY
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 4937014
• MDR Text Key: 6033987
• Report Number: 3010536692-2015-01419
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38HM-1048
• Device Lot Number: 037417528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/25/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR