MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM NEUTRAL; HIP SYSTEMS DJO SURGICAL

Catalog Number 400-03-362

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

Patient Problem Hip Fracture (2349)

Event Date 10/15/2023

Event Type  Injury  

Manufacturer Narrative

The agent reported "(peri prosthetic fracture)".The previous surgery and the surgery detailed in this event occurred 24 days apart.This evaluation is limited in scope as the items associated with this investigation were 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 the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.The root cause of this complaint was a revision surgery due to peri prosthetic fracture.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.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 or improper surgical technique, patient activities or trauma.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: 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 was an ncmr associated with the main part , which documents that out of 20 parts lot, all pats were rejected due to router packets were missing.Later, the rejected were reworked and accepted after proper justification.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.Complaint history: customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.

Event Description

Revision surgery - mdr - fracture.

• Brand Name: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM NEUTRAL
• Type of Device: HIP SYSTEMS DJO SURGICAL
• 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: 18088675
• MDR Text Key: 327586524
• Report Number: 1644408-2023-01586
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076135
• UDI-Public: 00888912076135
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082844
• 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: 11/07/2023

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 Catalogue Number: 400-03-362
• Device Lot Number: 866B2013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 425-97-006 , LOT 171R1144
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female