MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; COCR FEM HEAD 22MM +0 12/14 TAPER

Model Number	142-22-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation pending.Concomitant devices: (cn: 01-010-24-4195, sn: (b)(4)), mono rev stem std 24x195.
Event or Problem Description
As reported, a (b)(6) y/o male patient, who¿s primary tha was in 1985, presented with hip dislocations during hospitalization (b)(6) 2019 that required closed reductions.He completed antibiotic management with no new dislocation episodes and discharged on (b)(6) 2019, to a extended care facility.The case report form indicates this event is definitely not related to devices and possible related to procedure.This event report was received through clinical data collection activities.The case report form indicates this event was resolved on (b)(6) 2019 with closed reduction.No device removed, none to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the revision 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 dislocation, subsequent closed reduction, and medications cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition are the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.(d11) concomitant devices: (cn: 01-010-24-4195, sn: (b)(6)) mono rev stem std 24x195.Section h11: corrections made in the following section(s): (b3) event date corrected from (b)(6) 2019.

• Brand Name: EXACTECH
• Common Device Name: COCR FEM HEAD 22MM +0 12/14 TAPER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9985855
• Report Number: 1038671-2020-00281
• Device Sequence Number: 3896876
• Product Code: JDI
• UDI-Device Identifier: 10885862026729
• UDI-Public: 10885862026729
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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 Expiration Date: 12/05/2023
• Device Model Number: 142-22-00
• Device Catalogue Number: 142-22-00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 60