MAUDE Adverse Event Report: CONSENSUS ORTHOPEDICS, INC. CONSENSUS BI-POLAR ASSEMBLY

Catalog Number 1020-0-2247

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 12/17/2016

Event Type  Injury  

Event Description

On (b)(6) 2016: primary surgery of bipolar hip arthroplasty with 1210-0-0120 taper set stem (lot 481590).On (b)(6) 2016: the patient came to the hospital and sued pain in the hip joint.Dr.Found dislocation of bipolar cup from acetabulum and coming off of femoral head from bipolar head by x ray photograph.We could not obtain detailed information why dislocation and coming off occurred because the patient has dementia.On (b)(6) 2016: dr.Carried out revision surgery.The affected hip joint was changed to tha.On (b)(6) 2017: (b)(6) received only broken bipolar assembly.Dr.Would like to know why this phenomenon occurred.The taperset femoral stem lot 481590 was not returned to coi for investigation.

Manufacturer Narrative

Initial report was presented without evaluation being completed due to reporting for 30 day timeline to fda.Evaluation has been completed.

Event Description

On (b)(6) 2016: primary surgery of bipolar hip arthroplasty with 1210-0-0120 taper set stem (lot 481590).On (b)(6) 2016: the patient came to the hospital and sued pain in the hip joint.Dr.Found dislocation of bipolar cup from acetabulum and coming off of femoral head from bipolar head by x ray photograph.We could not obtain detailed information why dislocation and coming off occurred because the patient has dementia.On (b)(6) 2016: dr.Carried out revision surgery.The affected hip joint was changed to tha.On (b)(6) 2017: (b)(6).Received only broken bipolar assembly.Dr.Would like to know why this phenomenon occurred.The taperset femoral stem lot 481590 was not returned to coi for investigation.

Manufacturer Narrative

Date of this report was incorrect on initial report.Wrong date was 02/02/2017.Correct date is 02/07/2017.

• Brand Name: CONSENSUS BI-POLAR ASSEMBLY
• Type of Device: BI-POLAR ASSEMBLY
• Manufacturer (Section D): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; www.consensusortho.com; el dorado hills CA 95762
• Manufacturer (Section G): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; el dorado hills CA 95762
• Manufacturer Contact: dan lubeck ; 1115 windfield way; el dorado hills, CA 95762 ; 9163557158
• MDR Report Key: 6386017
• MDR Text Key: 69329473
• Report Number: 2952369-2017-00001
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K922560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2020
• Device Catalogue Number: 1020-0-2247
• Device Lot Number: 831681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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: 65 YR