MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL 40MM OD, +0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	170-40-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6) 164-01-13 - element-stem, collarless w/ha, std offset, sz 13.(b)(6) 180-01-56 - nv crown cup clstr hole 56mm group 3.
Event or Problem Description
It was reported that this 59 y/o male patient's left hip was revised approximately 5 years post op.The patient returned to surgeons office complaining of pain, swelling, and dissatisfaction with their left primary total hip.The poly and a recalled implant were in question and shown to be worn on x-ray.The patient underwent an acetabular poly implant and a femoral head swap.Patient was last known to be in stable condition following the event.Product not returning: implants are sent to the lab and legal.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: BIOLOX DELTA FEMORAL 40MM 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20233178
• Report Number: 1038671-2024-03551
• Device Sequence Number: 8637501
• Product Code: JDI
• UDI-Device Identifier: 10885862155504
• UDI-Public: 10885862155504
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 02/05/2024
• Device Catalogue Number: 170-40-00
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• 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 Age: 59 YR
• Patient Sex: Male