MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately twenty two days after initial tha, the female patient was brought back for a lesser trochanteric fracture.The head was removed, the stem removed.The fracture was reduced and cables.A size 10 hps stem was cemented along with a new 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 device is not available for evaluation.
Additional Manufacturer Narrative
Concomitants medical products: size 7 std taper wedge stem (cat# 188-07-01, (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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 twenty two days after initial tha, the female patient was brought back for a lesser trochanteric fracture.The patient did have a fall, but the date/time is not reported, the patient presented to the clinic not the emergency room for treatment.The head was removed, the stem removed.The fracture was reduced and cables.A size 10 hps stem was cemented along with a new 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 device is not available for evaluation due to implants sent off with tissue.No additional information is available.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 the surgical event cannot be conclusively determined; however, it is most likely related to patient conditions and a fall.These devices are used for treatment not diagnosis.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM
• 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: 14684390
• Report Number: 1038671-2022-00679
• Device Sequence Number: 5083934
• Product Code: JDI
• UDI-Device Identifier: 10885862155498
• UDI-Public: 10885862155498
• 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): 09/07/2022

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: 08/23/2025
• Device Model Number: BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM
• Device Catalogue Number: 170-36-07
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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