MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS

Model Number	136-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.(concomitant medical products) concomitant device: (cn: 186-01-56, sn (b)(4)) integrip cc cluster 56mm g3.(cn: 142-36-07, sn (b)(4)) cocr fem head 36mm +7 offset 12/14.(cn: 120-65-15, sn (b)(4)) bone screw 6.5 x 15.(cn: 120-65-30, sn (b)(4)) bone screw 6.5 x 30.(cn: 120-65-30, sn (b)(4)) bone screw 6.5 x 30.
Event or Problem Description
As reported, approximately 6 ½ years postop the initial left tha, this (b)(6) y/o female patient was revised due to cup malposition and poly wear.Surgeon implanted biolox delta option femoral head, 28mm and a biolox delta adapter, 16/18-12/14 +7, 170-50-07.Exactech stem remained intact.All other implants were removed and replaced with competitor¿s devices.Patient was last known to be in stable condition following the event.Devices not to return as hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported was likely the result of prosthesis wear of the acetabular liner and malposition of the acetabular cup.The prosthesis wear may have been a result of orientation of the acetabular cup, edge loading/impingement, and/or patient related conditions.It is unclear when the cup malposition occurred but may have been the result of being implanted at a poor angle or migration.However, this cannot be confirmed because the components were not returned for evaluation.(d11) concomitant device: - (b)(6).Integrip cc cluster 56mm g3.- (b)(6).Cocr fem head 36mm +7 offset 12/14.- (b)(6).Bone screw 6.5 x 15.- (b)(6).Bone screw 6.5 x 30.- (b)(6).Bone screw 6.5 x 30.No information provided in the following section(s): a4, a5, b6, the following section(s) have additional info: g4, g5, g7, h1, h2, h3, and h7.

• Brand Name: NOVATION
• Common Device Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10721615
• Report Number: 1038671-2020-00586
• Device Sequence Number: 3141006
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (Y/N): N
• PMA/510(K) Number: K070479
• 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): 12/22/2020

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: 09/10/2018
• Device Model Number: 136-36-53
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: 75 YR