MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; MONO REV STEM STD 24X195

Model Number	01-010-24-4195
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.
Event or Problem Description
Index surgery: (b)(6) 2019.Four days later on (b)(6) 2019, cultures report positive for e.Faecium, with infectiology, antibiotic management and prosthesis retention protocol are initiated.The case report form indicates this event is definitely dot related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
Event or Problem Description
As reported, this patient's most recent revision surgery: (b)(6) 2019.A 62 y/o male patient who is 5¿5¿ and weighs 132 lbs., experienced a right tha revision of a competitor¿s device on (b)(6) 2019.Four days post-op, wound cultures report positive for e.Faecium, with infectiology, antibiotic management and prosthesis retention protocol were initiated.The reason for the initial revision of a competitor¿s devices was not reported to the study.The patient is reported as a long-time smoker.The patient was discharged to an extended care facility on a walker.The study information documents the patient¿s ¿complication¿ status at discharge as ¿resolved¿ on (b)(6) 2019.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 initial rha was completed in 1985 due to a fracture.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted as reported, this patient's most recent revision surgery: (b)(6) 2019.A 62 y/o male patient who is 5¿5¿ and weighs 132 lbs., experienced a right tha revision of a competitor¿s device on (b)(6) 2019.Four days post-op, wound cultures report positive for e.Faecium, with infectiology, antibiotic management and prosthesis retention protocol were initiated.The reason for the initial revision of a competitor¿s devices was not reported to the study.The patient is reported as a long-time smoker.The patient was discharged to an extended care facility on a walker.The study information documents the patient¿s ¿complication¿ status at discharge as ¿resolved¿ on (b)(6) 2019.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 initial rha was completed in 1985 due to a fracture.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 infection and subsequent treatment cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and nosocomial in origin.(d11) concomitant device: femoral head (cn: (b)(4), sn: (b)(6) no information provided in the following section(s): d4 (serial number and expiration date).

• Brand Name: ALTEON
• Common Device Name: MONO REV STEM STD 24X195
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9070029
• Report Number: 1038671-2019-00460
• Device Sequence Number: 3042224
• Product Code: LZO
• UDI-Device Identifier: 10885862281951
• UDI-Public: 10885862281951
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 01-010-24-4195
• Device Catalogue Number: 01-010-24-4195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Weight: 60