MAUDE Adverse Event Report: ENCORE MEDICAL L.P SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 412-02-044

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 02/21/2023

Event Type  Injury  

Event Description

Revision surgery - due to pain.

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(pt presented to dr with pain in left hip following hemi bipolar hip placement.No idea of how long the bipolar hip has been in.Dr and patient agreed to a revision and placement of a cup and liner for a total hip.Female 72)." the previous surgery and the surgery detailed in this event occurred 5.7 years apart.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate that the reported device(s) was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to pain.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.

• Brand Name: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 16570216
• MDR Text Key: 311557657
• Report Number: 1644408-2023-00321
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077361
• UDI-Public: 00888912077361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2022
• Device Model Number: 412-02-044
• Device Catalogue Number: 412-02-044
• Device Lot Number: 988B1146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 497-28-035 LOT: 631C1233
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female