MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: wedge plasma s/o sz 5 (cat# 188-00-05 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eighteen days post initial left tha, this female patient was brought back for left hip trauma, lesser trochanteric fracture, the hip was dislocated, femoral head removed and stem removed.The fracture was reduced using cable system, a size 6 hps stem was cemented with a 36+3.5 biolox head.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray received.The devices will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately eighteen days post initial left tha, this female patient was brought back for left hip trauma, lesser trochanteric fracture and the hip was dislocated the femoral head and stem were removed.The fracture was reduced using a cable system, a size 6 hps stem was cemented with a 36+3.5 (ceramic) head.The cause, type, and date of trauma are not known.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray received.The devices will be return.The representative provided the additional information on 29 aug 22: "i¿m not sure of the type of trauma.I am assuming a fall [,] not sure the exact date it happened." no other information provided.There is no information about the supposed patient fall to determine implant participation in the event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of hip trauma and surgical revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14220189
• Report Number: 1038671-2022-00479
• Device Sequence Number: 4194764
• Product Code: JDI
• UDI-Device Identifier: 10885862155474
• UDI-Public: 10885862155474
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 01/07/2026
• Device Model Number: BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM
• Device Catalogue Number: 170-36-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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 Sex: Female