MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE46

Model Number 412-02-046

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 02/19/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient not following surgeon's instructions, and dislocating bipolar from hip socket after crossing her legs.Emergency room surgeon disengaged head from stem while trying to reduce.A longer neck and offset stem were added.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due to the patient not following instructions and dislocating.The previous surgery and the revision detailed in this investigation occurred 8 days apart.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to this event.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to the patient not following instructions and dislocating.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to the patient not following surgeon's instructions, and dislocating bipolar from hip socket after crossing her legs.Emergency room surgeon disengaged head from stem while trying to reduce.A longer neck and lateral offset stem were added.

• Brand Name: BIPOLAR HIP
• Type of Device: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE46
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7313538
• MDR Text Key: 101507300
• Report Number: 1644408-2018-00194
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077378
• UDI-Public: (01)00888912077378
• Combination Product (y/n): N
• PMA/PMN Number: K953510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: 412-02-046
• Device Catalogue Number: 412-02-046
• Device Lot Number: 991B1154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 425-98-011, LOT 563G1087; 497-28-700, LOT 635C1157; 425-98-011, LOT 563G1087; 497-28-700, LOT 635C1157
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR