MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EXPRT HIP; EXPRT REVISION HIP, TRIAL PROXIMAL BODY CAPTURE BOLT, 75MM

Model Number	803-95-275
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2021
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 - expert hip with surgeon implanted distal stem.Went to trial proximal body.Inserted trial proximal body and cranked on the implanted trial screw distal to make sure it was tight.The trial proximal body came loose during reduction and spun around the implanted distal stem.Once proximal body is loose, surgeon looses his version during and can not gauge stability of the construct.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this instrument failure was reported as loosening.The healthcare professional indicated there was a significant adverse event to the patient and the event occurred during surgery, near the patient.The surgery was completed as intended, with a five to ten-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The devices were disposed of at hospital and evaluated by registered medical assistant (rma) at djo surgical.The instruments were not returned for examination and the lot numbers were not reported.Without the lot number, the instrument could not be linked to a specific device history records (dhr) and the actual date of manufacture cannot be determined with confidence.Complaint database review shows no prior complaints filed against the instruments item and lot number that reports a similar failure.No prior complaints report past instances of these instruments being affected by this failure.The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.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 not returned to djo, and no further evaluation can be made for this event.The rep/agency was contacted and confirmed they will not be sending the instruments to djo for investigation.This customer complaint will be closed.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EXPRT HIP
• Common Device Name: EXPRT REVISION HIP, TRIAL PROXIMAL BODY CAPTURE BOLT, 75MM
• 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12500469
• Report Number: 1644408-2021-00997
• Device Sequence Number: 13786893
• Product Code: KWZ
• UDI-Device Identifier: 00190446156031
• UDI-Public: (01)00190446156031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 803-95-275
• Device Catalogue Number: 803-95-275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 803-95-075 LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male