MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: nv gxl lnr, +5lat, 36mm g2-52/54mm cups (cat# 136-36-52), alteon 6.5mm screw, 20mm (cat# 180-65-20) , integrip cc, cluster 52mm, g2 (cat# 186-01-52) ,and biolox delta femoral head 36mm od, +0mm (cat# 170-36-00).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial right side tha, this male patient was revised due to osteolysis and the stem was also subsided.Patient received depuy implants.There was no breakage of device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos or x-rays.The devices are not available for evaluation due to hospital keep the implants.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, g3, g6, h2, h3, h4 and h6 have been updated accordingly.(h3) the revision reported was likely the result of osteolysis and femoral stem subsidence, which may have been due to an under sized femoral stem for the patient¿s anatomy/femoral bone or insufficient bony support for the femoral stem.However, this cannot be confirmed as the explants were not available for evaluation and x-ray images were not provided.The most probable root cause associated with the reported event of "femoral stem subsidence¿ is associated with a femoral stem that subsides into the prepared femoral canal further than expected.This can occur during implantation or post-operatively.Furthermore, the most probable root cause associated with the reported event of "osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 36MM 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13690659
• Report Number: 1038671-2022-00241
• Device Sequence Number: 5170408
• Product Code: JDI
• UDI-Device Identifier: 10885862320926
• UDI-Public: 10885862320926
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM
• Device Catalogue Number: 170-36-00
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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: Male