MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; WEDGE PLASMA S/O SZ 9

Catalog Number	188-00-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the initial implant date was (b)(6) 2019.This (b)(6) female was revised on (b)(6) 2019 due to left hip stem fracture.The device was discarded upon revision by the facility.Patient was last known to be in stable condition following the event.No other information available at this time.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of either patient¿s poor bone quality, an intra-operative bone fracture that was not noticed during the original surgery, or a combination of the two, which led to a periprosthetic bone fracture.However, this cannot be confirmed as the device was not available for evaluation.Concomitant device(s): - cemented finned tib.Tra sz 3f/3t (cn: 200-04-33, sn: (b)(6)).

• Brand Name: ALTEON
• Common Device Name: WEDGE PLASMA S/O SZ 9
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9521091
• Report Number: 1038671-2019-00631
• Device Sequence Number: 16280303
• Product Code: JDI
• UDI-Device Identifier: 10885862250810
• UDI-Public: 10885862250810
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 05/22/2024
• Device Catalogue Number: 188-00-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/20/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 47 YR