MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM

Model Number	01-010-16-4195
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, in the immediate post op period, a hematoma is observed, two days later the hematoma was drained and surgical washing.The patient continued with pain with difficult management and the patient was taken for another washout.11 days later, frank pus was observed, the prosthesis retention protocol for peri-prosthetic infection is started, antibiotic management is started, patient is still hospitalized.The case report form indicates this event is definitely not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.The case report form indicates this event is continuing with medications and monitoring.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the reported revision noted that based upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient¿s condition.
Event or Problem Description
As reported, this patient¿s initial tha with a competitor¿s devices in 2005.On (b)(6) 2019, this 44 y/o female patient, weight 171 lbs., experienced a previous revision of another manufacturer¿s devices due to aseptic loosening.On (b)(6) 2020, the patient underwent an arthrocentesis due to the appearance of a hematoma on (b)(6) 2020.The patient continued with pain and difficult management.Eleven days later, frank pus was observed and the hospital¿s ¿prosthesis retention protocol for peri-prosthetic infection¿ is started, antibiotic management is started, and the patient is still hospitalized.The patient was taken for more ¿washouts¿ on (b)(6) 2020.On (b)(6), previously inserted hemovac drain was removed.On (b)(6) 2020, this patient underwent a revision for infection, which includes this manufacturer¿s devices.

• Brand Name: EXACTECH
• Common Device Name: BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9953115
• Report Number: 1038671-2020-00271
• Device Sequence Number: 14150528
• Product Code: LZO
• UDI-Device Identifier: 10885862281876
• UDI-Public: 10885862281876
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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 Model Number: 01-010-16-4195
• Device Catalogue Number: 170-28-00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 78