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
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2024-00339
• Device Sequence Number: 7143925
• Product Code: JDI
• UDI-Device Identifier: 10885862155580
• UDI-Public: 10885862155580
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2024
• Device Catalogue Number: 170-40-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female