MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN HIP COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	170-36-93
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right hip replacement on (b)(6) 2015.Approximately 3 months after the initial procedure the patient had a right hip revision on (b)(6) 2016.The patient developed an early deep periprosthetic infection.An excisional arthroplasty of his hip with removal of the total hip replacement and insertion of an antibiotic articulating spacer.6 weeks of iv antibiotics.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2016: diagnosis: history of infected total right hip: findings: 1.Intraoperative findings showed no gross evidence of infection 2.Intraoperative frozen sections of the worst-appearing tissue in the periacetabular regions showed no evidence of acute inflammation.There was mild to moderate contained bone loss of the proximal femur and acetabulum.The patient was transferred from the operating room to the recovery room in stable condition, having tolerated the procedure well.
Additional Manufacturer Narrative
D10: concomitants: 4148717 101-45-20 - 4.5mm drill bit 20mm; 4157494 180-65-30 - alteon 6.5mm screw, 30mm; 4043131 186-01-58 - integrip cc, cluster 58mm, g3; 4043927 188-01-11 - wedge plasma x/o sz 11; 4076031 130-36-53 - nv gxl linr, ntrl, 36mm id, group 3 cups.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.
Additional Manufacturer Narrative
H10.Additional information- a3, g2, h6 medical device problem code.H3.Investigation results- there is no mention of device malfunction in the operative report.The intraoperative findings showed no gross evidence of infection.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Ifu-general surgical risks include superficial or deep infection.These devices are used for treatment not diagnosis.There is no additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, d4, g4, h4, h6 - type of investigation and h11 there is no mention of device malfunction in the operative report.The intraoperative findings showed no gross evidence of infection.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: UNKNOWN HIP COMPONENTS
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18100128
• Report Number: 1038671-2023-02724
• Device Sequence Number: 12692277
• Product Code: JDI
• UDI-Device Identifier: 10885862155481
• UDI-Public: 10885862155481
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• 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,Followup
• Report Date (Section B): 04/06/2026

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 Expiration Date: 08/17/2020
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 05/31/2024; 04/02/2026
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 05/31/2024; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male