MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	170-32-00
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): (b)(4) 132-32-51 - nv gxl liner lipped 32mm id, group 1 cups.(b)(4) 180-65-20 - alteon 6.5mm screw, 20mm.(b)(4) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(4) 186-01-48 - integrip cc, cluster 48mm, g1.(b)(4) 190-20-03 - alt ha s noclr std sz 3.
Event or Problem Description
It was reported that this 62 y/o female patient presented back to the surgeon's office with complaints of their right revised hip.The surgeon's office report mentions some medial healing of the medial wall fracture, however he is concerned about loosening of the acetabular implant.A review of the bone scan showed increased uptake around the hip implant.The patient was scheduled for more testing to evaluate the remaining bone stock for choice or revision implant options.The patient was booked for a second revision right tha on (b)(6) 2023.This revision involved the exactech stem and 28mm head.During the revision, the acetabular components were removed and the stem and head were removed.A revision alteon monoblock implant and 28mm head were reimplanted on the femoral side.Djo was re-implanted on the acetabular side.Patient was last known to be in stable condition following the event.Devices are not returning, the implants were saved for lab and legal at the hospital.
Additional Manufacturer Narrative
Section h10: (h3) event has been determined to be non-valid.Competitors products were involved.Please disregard.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16700469
• Report Number: 1038671-2023-00608
• Device Sequence Number: 14853904
• Product Code: JDI
• UDI-Device Identifier: 10885862153623
• UDI-Public: 10885862153623
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2021
• Device Catalogue Number: 170-32-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 73 KG