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

Catalog Number	170-36-93
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction: please disregard previous report as it was reported in error.There is no allegation against the femoral head and it is common practice to replace the head when revising the liner.
Additional Manufacturer Narrative
Pending investigation.D10: 4368463 180-65-25 - alteon 6.5mm screw, 25mm 4431117 180-65-25 - alteon 6.5mm screw, 25mm 4414457 186-01-52 - integrip cc, cluster 52mm, g2 4229675 188-01-04 - wedge plasma x/o sz 4 4190809 101-45-20 - 4.5mm drill bit 20mm.
Event or Problem Description
As reported, a patient had their hip revised.The gxl liner and ceramic head where replaced with the same implants and sizes.The event is not related to the breakage of a device.The event did not cause a surgical.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19741292
• Report Number: 1038671-2024-02390
• Device Sequence Number: 3641569
• Product Code: LPH
• UDI-Device Identifier: 10885862027931
• UDI-Public: 10885862027931
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K050398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 170-36-93
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female