MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP

Model Number	138-32-51
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: (cn: 142-32-00, sn: (b)(4) cocr fem head 32mm +0 offset 12/14.
Event or Problem Description
As reported, approximately 9 yrs and 5 mos.Postop the initial implant, this female, (b)(6) years old, was revised.The surgeon removed the left side liner and replaced it with the same one.He upsized the head by 3.5mm to give the person better stability.Patent was revised to 10 degree liner, 32mm femoral head and adapter 16/18-12/14, +3.5mm.Patient was last known to be in stable condition following the event.Hospital threw away devices, not returning.
Additional Manufacturer Narrative
(h3) the evaluation of the revision based on review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.(d11) concomitant device: (cn: 142-32-00, sn: (b)(6) cocr fem head 32mm +0 offset 12/14.

• Brand Name: NOVATION
• Common Device Name: NV GXL LNR, 10 DEG FACE, 32MM ID, GRP 1 CUP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10262060
• Report Number: 1038671-2020-00333
• Device Sequence Number: 3017834
• Product Code: JDI
• UDI-Device Identifier: 10885862024732
• UDI-Public: 10885862024732
• Combination Product (Y/N): N
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 01/26/2014
• Device Model Number: 138-32-51
• Device Catalogue Number: 138-32-51
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR