MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; EMPOWR ACET DM, THREADED HEAD TRIAL, 42MM

Model Number	803-15-142
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure while trailing on a total hip, the dual mobility head trial was positioning up and down the trunnion of the broach trial, and surgeon was unable to create enough traction to dislocate the hip.Surgeon took a power cork screw and drilled it in to the trial and this allowed him to dislocate the hip.
Additional Manufacturer Narrative
Corrected data: manufacturer narrative: the reason for this instrument failure was reported as surgical delay.The possible time in service of the main contributor of this complaint is 7 months from manufactured date.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported.The surgery was completed as intended, with a twenty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the instrument's device history records (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the production of this instrument.Complaint database review shows no prior complaints filed against the instrument item number that reports a similar failure.The root cause of this complaint is likely attributable to the traction between the trunnion and the head trial sleeve.The connections between these parts are quite smooth which could have resulted in the surgeon being unable to dislocate the hip.This is not an event associated with a product failure, malfunction, or issue.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was returned to djo and after further examination, the threaded head trial and the threaded offset sleeve have holes through the side, indicative of a power drill.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR HIP
• Common Device Name: EMPOWR ACET DM, THREADED HEAD TRIAL, 42MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 13893817
• Report Number: 1644408-2022-00335
• Device Sequence Number: 19986852
• Product Code: LPH
• UDI-Device Identifier: 00190446689843
• UDI-Public: (01)00190446689843
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 803-15-142
• Device Catalogue Number: 803-15-142
• Device Lot Number: 351272L07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 803-15-110 LOT 351270L03; 803-15-113 LOT 351270L03
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 75 KG