MAUDE Adverse Event Report: ENCORE MEDICAL L.P HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM -4.0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 400-03-361

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2024

Event Type  Injury  

Event Description

Revision surgery - due to the implant given to the doctor was bigger than the trial one.

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(the implant given to the doctor was bigger than the trial one)".The previous surgery and the surgery detailed in this event occurred 03 days apart.This evaluation is limited in scope as the item associated with this investigation were not returned to djo surgical - austin for review.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 device 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 (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device 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 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 the implant was bigger than the trial one.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, incorrect implant selection, patient activities or trauma.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.

• Brand Name: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM -4.0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 18966133
• MDR Text Key: 338434354
• Report Number: 1644408-2024-00329
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076128
• UDI-Public: 00888912076128
• 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: 03/22/2024

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: 400-03-361
• Device Lot Number: 864B1772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female