MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CERAMIC AHS; NV AHS CERAMIC LINER GROUP 3

Model Number	140-36-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: novation ceramic ahs shell, 140-01-54; bone screws; 36 - 3.5 alunia head, 140-36-93.
Event or Problem Description
One year ago, approximately (b)(6) of 2019, the patient presented with a squeaking in her operative hip.The initial left tha was completed approximately 5 years prior.The (b)(6) y/o female patient has a ¿high bmi¿ and was in pain leading up to the revision.The ceramic liner fractured.The ceramic head lodged into a hole in the cup and bore through.The cup, screws, and liner fragments were removed.The ceramic head was removed as well and revised to a competitive cup with a ceramic option head.Patient was last known to be in stable condition following the event.Devices was disposed of by the facility.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision was likely the result of the ceramic liner fracture which led to subsequent wear of the acetabular cup due to contact with the femoral head.The reason for the ceramic liner fracture could not be determined based on the information provided.Concomitant devices: novation ceramic ahs shell, 140-01-54; bone screws; 36 - 3.5 alunia head, 140-36-93.No information provided in the following section(s): a4, a5, b6.The following section(s) have additional info: d4 (serial number, and exp date), g4, g7, h1, h2, h3, h4 and h7.Section h11: corrections made in the following section(s): (g4) the awarness date in the initial submission should have been 24-jul-2020.

• Brand Name: NOVATION CERAMIC AHS
• Common Device Name: NV AHS CERAMIC LINER GROUP 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10417700
• Report Number: 1038671-2020-00488
• Device Sequence Number: 3190314
• Product Code: MRA
• UDI-Device Identifier: 10885862025524
• UDI-Public: 10885862025524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 06/12/2019
• Device Model Number: 140-36-13
• Device Catalogue Number: 140-36-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR