MAUDE Adverse Event Report: ENCORE MEDICAL L.P TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 12

Model Number	425-97-012
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/29/2022
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
Complaint - surgeon trialed with the broach size that was appropriate for the patient.When the implant was placed it subsided causing the hip to be unstable.Implants had to be taken out and replaced.
Additional Manufacturer Narrative
The reason for this complaint was reported as broaching technique causing the stem to subside.The healthcare professional indicated this event occurred during treatment near the patient.There was another suitable device available, however, the incident did cause a 40 minute delay in surgery.The surgery was completed as intended, there was no risk or adverse event reported and the item was inspected prior to surgery and was found to be acceptable.The device was not returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the device history record (dhr) revealed, when released for use, the items met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed previous complaints but there were no indications that this component has a design or material deficiency.To date number of complaints against this lot no.: 0 summary of complaints to date: finished goods.S103 - fit 1 finished goods.S301 - taper damage 1 finished goods.S800 - revision surgery 3 finished goods.S803 - dislocation 1 finished goods.S807 - pain 1 finished goods.S808 - infection 3 finished goods.S809 - trauma 6 finished goods.S810 - device loosening 2 this event is possibly attributable to broaching technique causing the stem to subside.This is not an event associated with a product failure, malfunction or issue.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 12
• 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: 14105056
• Report Number: 1644408-2022-00504
• Device Sequence Number: 20439981
• Product Code: LPH
• UDI-Device Identifier: 00888912078702
• UDI-Public: (01)00888912078702
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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: 425-97-012
• Device Catalogue Number: 425-97-012
• Device Lot Number: 177R2237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female