MAUDE Adverse Event Report: ENCORE MEDICAL L.P SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 412-02-050

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

Patient Problem Insufficient Information (4580)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(patient fell during post-op pt.Pulled everything out, and we moved to expert stem and new bipolar constant)".The previous surgery and the surgery detailed in this event occurred 16 days apart.This evaluation is limited in scope as the items associated with this investigation were not returned to (b)(6) 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 the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices 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 a fall.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.Agent has clearly mentioned that "patient fell" and due to short time between previous and revision surgery, it is possible that the event may have occurred due to lack of post-operative care, patient noncompliance with medical instructions, incorrect implant selection, patient activities or trauma.There are multiple factors that may also contribute to an event that are outside the control of (b)(6).

Event Description

Revision surgery - due to patient fell post op.

• Brand Name: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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: 16315510
• MDR Text Key: 309012729
• Report Number: 1644408-2023-00149
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077415
• UDI-Public: 00888912077415
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412-02-050
• Device Catalogue Number: 412-02-050
• Device Lot Number: 997B1103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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: 425-97-010 LOT: 175R2257.; 497-28-035 LOT: 631C1418.
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female