MAUDE Adverse Event Report: CONSENSUS ORTHOPEDICS, INC. BIPOLAR ASSEMBLY

Catalog Number 1020-0-2843

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 03/10/2019

Event Type  Injury  

Manufacturer Narrative

Discussion: the incident, involving the patient's fall while going to the bathroom, was evaluated for possible cause of hip dislocation.The bipolar head most likely dislocated from the acetabulum due to the patient falling prior to entering the emergency room and prior to manipulation.The surgeon's attempt at manipulating the hip, most likely lead to component dissociation, however this was unrelated to the incident of the patient falling.Due to limited information on how the patient fell, it is unknown what mechanism caused the bipolar head to dislocate from the hip socket.The preassembled bipolar head and unisyn stem were apparently functioning as intended prior to the fall.The dhr review revealed no abnormalities pertaining to qc inspection or processing of the implant components used in primary surgery.Radiographs indicated adequate component assembly and positioning in the patient at time of primary surgery.There were no indications of component dissociation prior to the surgeon's attempt at manipulating the hip.In summary, the actual cause of the bipolar head dislocation from the hip socket remains inconclusive.

Event Description

Disassociation of the femoral head from bipolar lining.

• Brand Name: BIPOLAR ASSEMBLY
• Type of Device: BIPOLAR ASSEMBLY
• Manufacturer (Section D): CONSENSUS ORTHOPEDICS, INC.; 1115 windfield way; 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 ; 9163557100
• MDR Report Key: 8516147
• MDR Text Key: 142042431
• Report Number: 2952369-2019-00001
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00844588016103
• UDI-Public: 00844588016103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Catalogue Number: 1020-0-2843
• Device Lot Number: 830667A2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: 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: 53 YR