MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 170-40-50

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteolysis (2377)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

H10.Pending investigation.These devices are used for treatment not diagnosis.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a first right total hip revision on (b)(6) 2023 and then approximately 7 months later experienced a second surgical revision on (b)(6) 2023.Revision operative report of (b)(6)2023: aseptic loosening of acetabular component/ acetabular periprosthetic fracture with pelvic discontinuity/ severe acetabular bone loss.Revised to competitor¿s devices.There was significant osteolysis in the proximal femur.The acetabular component was grossly loose and migrated into the pelvis.Liner was removed, three loose screws.There was significant bone loss in the acetabulum with severe ilium and pubic osteolysis as well as acetabular periprosthetic fracture involving the anterior and posterior column in a true pelvic discontinuity mode.The patient was transferred to the recovery room in stable condition.There is no other information available.The patient had a previous right hip revision on (b)(6) 2023 [mfr (b)(4) , where there was extensive osteolysis of the pubis and bone loss noted.The periprosthetic fracture noted at (b)(6) 2023 surgery is most likely due to the extensive osteolysis/bone loss that was noted in the on (b)(6) 2023 surgery.There is no other information available.

Manufacturer Narrative

G4 510k, and h4 after investigation engineering has determined that the revised devices were competitor's devices.That information will be forwarded to the manufacturer.

• Brand Name: BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18804373
• MDR Text Key: 336506676
• Report Number: 1038671-2024-00339
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862155580
• UDI-Public: 10885862155580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• 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: 03/11/2024

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: 170-40-50
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female