MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIOLOX DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 44MM

Catalog Number 400-04-440

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

Patient Problem Sepsis (2067)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-01516, 400-04-320, s800 - revision surgery, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - patient has multiple comorbidities.Did washout, sepsis noticed and replaced head and sleeve.

• Brand Name: BIOLOX DELTA HIP
• Type of Device: HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 44MM
• 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: 18204854
• MDR Text Key: 328918613
• Report Number: 1644408-2023-01688
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076289
• UDI-Public: (01)00888912076289
• 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: 11/23/2023

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: 03/04/2024
• Device Catalogue Number: 400-04-440
• Device Lot Number: 885B1034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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: 400-05-000 LOT 886B1288
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female