MAUDE Adverse Event Report: ENCORE MEDICAL L.P SLEEVE, UNIPOLAR, OFFSET -3.5; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 411-00-035

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

Patient Problem Unspecified Infection (1930)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(infection, wound closure)." the previous surgery and the surgery detailed in this event occurred 4 months apart.This evaluation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information 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 the source or had a direct connection with the patient's infection.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 an infection.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 possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.

Event Description

Revision surgery - due to infection.

Manufacturer Narrative

The reason for this follow up is to correct a2 date of birth was missing and h5.

• Brand Name: SLEEVE, UNIPOLAR, OFFSET -3.5
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 16275110
• MDR Text Key: 308522068
• Report Number: 1644408-2023-00089
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00888912023412
• UDI-Public: 00888912023412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973614
• 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,Followup
• Report Date: 02/08/2023

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 Model Number: 411-00-035
• Device Catalogue Number: 411-00-035
• Device Lot Number: 903B2071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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: 411-00-144 LOT: 911B1061.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female