MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; STEM, HIP, FH 460 SERIES SIZE15

Model Number	460-01-150
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this complaint was reported as stem pierced through protective package.The healthcare professional indicated that this event occurred during surgery, near the patient.A significant adverse event was reported by the surgeon.The surgery was completed as intended, with a ten-minute delay.The device was inspected prior to use and was deemed unacceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the device history record (dhr) for both items revealed the devices, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of either device.Complaint database review shows no prior complaints filed against the instruments item number that reports a similar failure.The root cause of this complaint is likely due to the package being misused or handled in a rough manner resulting in the stems piercing through the package.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the reported devices were returned to djo surgical for evaluation.There is a small puncture hole present on the external packaging as well as the internal packaging.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Complaint - stems pierce through protective package.

• Brand Name: FOUNDATION HIP
• Common Device Name: STEM, HIP, FH 460 SERIES SIZE15
• 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: 15099468
• Report Number: 1644408-2022-00989
• Device Sequence Number: 14749366
• Product Code: JDI
• UDI-Device Identifier: 00888912086202
• UDI-Public: (01)00888912086202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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 Expiration Date: 04/05/2023
• Device Model Number: 460-01-150
• Device Catalogue Number: 460-01-150
• Device Lot Number: 557C1916
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 460-01-165 LOT 559C1918; 460-01-165 LOT 559C1918
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male