MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

Model Number	186-01-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: biolox delta femoral head 28mm od, -3.5mm (cn: 170-28-93; sn: (b)(4)); element stem, collared w/ ha, std offset, sz 13 (cn: 164-03-13; sn: (b)(4)); novation gxl liner, neutral, 28mm id, group 1 (cn: 130-28-51; sn: (b)(4)).
Event or Problem Description
It was reported that the primary surgery occurred on (b)(6) 2014.The patient called exactech asking if there was a recall on her implanted devices.She is pending a revision on (b)(6) because her cup or liner has gone bad.Concomitant devices: biolox delta femoral head 28mm od, -3.5mm (cn: 170-28-93; sn: (b)(4)); element stem, collared w/ ha, std offset, sz 13 (cn: 164-03-13; sn: (b)(4)); novation gxl liner, neutral, 28mm id, group 1 (cn: 130-28-51; sn: (b)(4)).
Additional Manufacturer Narrative
Pending evaluation (d11) concomitant devices: biolox delta femoral head 28mm od, -3.5mm (cn: 170-28-93; sn: (b)(6).) novation gxl liner, neutral, 28mm id, group 1 (cn: 130-28-51; sn: (b)(6).).
Event or Problem Description
Index surgery: (b)(6) 2014.The patient called exactech asking if there was a recall on her implanted devices.She is pending a revision on (b)(6) because her cup or liner has gone bad.Update: (b)(6) 2020: patient was revised on (b)(6) 2019 due to reason not reported.Concomitant devices: biolox delta femoral head 28mm od, -3.5mm (cn: 170-28-93; sn: (b)(6)) novation gxl liner, neutral, 28mm id, group 1 (cn: 130-28-51; sn: (b)(6)).
Additional Manufacturer Narrative
*section h10: (h3) the evaluation noted in the revision reported could not be determined, but was likely the result of either wear, loosening, infection, or instability.However, this cannot be confirmed because the explants were not available for evaluation and no further information was provided.(d11) concomitant devices: biolox delta femoral head 28mm od, -3.5mm (cn: 170-28-93; sn: (b)(6)) novation gxl liner, neutral, 28mm id, group 1 (cn: 130-28-51; sn: (b)(6) no information provided in the following section(s): a2, a4, a5, b6, b7, e3, h6, h7.

• Brand Name: NOVATION
• Common Device Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9278727
• Report Number: 1038671-2019-00559
• Device Sequence Number: 345436
• Product Code: JDI
• UDI-Device Identifier: 10885862038760
• UDI-Public: 10885862038760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2020

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: 09/12/2017
• Device Model Number: 186-01-50
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 02/26/2020; 07/15/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 03/23/2020; 09/14/2020
• 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