MAUDE Adverse Event Report: ENCORE MEDICAL L.P LINEAR, LATERAL, REDUCED NECK, SZ 7, W/P2 COATING; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	425-99-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
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
Primary surgery: the femur fractured when the surgeon was inserting the primary stem.
Additional Manufacturer Narrative
The agent reported "(the femur fractured when the surgeon was inserting the primary stem, so he explanted it and used the exprt line to finish the case.Female 60 yrs)." the item was lost/discarded.This event occurred during surgery near the patient.There was another suitable device available.The incident did cause a 2-3 min.Delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the device was inspected prior to surgery and was found to be acceptable.Surgical devices condition can be determined while being used for its intended purpose.The replacement of surgical devices due to unavoidable incidences do not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.A review of the device history records (dhr) revealed, when released for use, the item(s) met design and manufacturing requirements.Complaint database review showed no previous complaints with the same description of the event.This event is attributable to the femur fractured when the surgeon was inserting the primary stem.The fracture could be a result of excessive forces experienced during broaching or poor quality of bone and no information with respect to the patient's bone quality was available to analyze.Also, reaming and broaching procedures may lead to potential fracture of the femur.This is not an event associated with a product failure, malfunction or issue.

• Brand Name: LINEAR, LATERAL, REDUCED NECK, SZ 7, W/P2 COATING
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16401937
• Report Number: 1644408-2023-00132
• Device Sequence Number: 5706114
• Product Code: LPH
• UDI-Device Identifier: 00888912078931
• UDI-Public: 00888912078931
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 425-99-007
• Device Catalogue Number: 425-99-007
• Device Lot Number: 572G1114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female