MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; PF STEM TAPERED PLASMA EXT OFFSET SZ 15

Model Number	160-01-15
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device: nv gxl liner neutral (cn: 130-36-52, sn: (b)(4)); 12/14 biolox femoral 36mm +0 (cn: 140-36-00, sn: (b)(4).
Event or Problem Description
As reported, approximately 4.5 years post the initial implant of right hip, a (b)(6) y/o female patient complained of hip pain and was revised due to the stem was loose.The surgeon retained the cup, replaced the liner, and removed the stem.The liner was replaced with another exactech liner.The stem was removed and a competitive revision stem was utilized.Patient was last known to be in stable condition following the event.Discarded at time of surgery.
Additional Manufacturer Narrative
Section h10: (h3): the evaluation noted in the revision reported was likely the result of insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral stem.However, this cannot be confirmed because the component was not returned for evaluation.Section (d11) concomitant device: nv gxl liner neutral (cn: 130-36-52, sn: (b)(6).12/14 biolox femoral 36mm +0 (cn: 140-36-00, sn: (b)(6).The following section(s) have additional info; d4 (serial number, and exp date).Section h11: corrections made in the following section(s): (d4) serial number, and expiration date).(d11) concomitant devices.(h4) manufactured date.

• Brand Name: NOVATION
• Common Device Name: PF STEM TAPERED PLASMA EXT OFFSET SZ 15
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10298882
• Report Number: 1038671-2020-00355
• Device Sequence Number: 14317419
• Product Code: JDI
• UDI-Device Identifier: 10885862031822
• UDI-Public: 10885862031822
• Combination Product (Y/N): N
• PMA/510(K) Number: K042842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 03/22/2020
• Device Model Number: 160-01-15
• Device Catalogue Number: 160-01-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: Required Intervention
• Patient Age: 71 YR