MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV CWN CUP NO HOLE W/HA 62MM GROUP 4

Model Number	180-10-62
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: cocr femoral head (cat# 142-32-03 / sn# (b)(4)), gxl liner (cat# 132-32-54 / sn# (b)(4)).
Event or Problem Description
It was reported that a patient suffered severe bone loss and required a revision.Device will not return according to hospital policy.This is a (b)(6) y/o male who weights (b)(6) lbs.
Event or Problem Description
As reported, revision was scheduled for a right hip that was initially implanted in 2011.The patient suffered severe bone loss due to osteolysis and needed to be revised.The surgeon revised the shell, gxl liner, and head.Devices are not returned per hospital policy.All available information received at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported that upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.The most likely cause for the osteolysis was the patient conditions.(d11) concomitant device(s): cocr femoral head (cat# 142-32-03 / (b)(6).Gxl liner (cat# 132-32-54 / (b)(6).No information provided in the following section(s): a5, b6, and d4 (serial number and expiration date).The following section(s) have additional info; b5, g7, h1, h2, h3, h4, and h7.

• Brand Name: NOVATION
• Common Device Name: NV CWN CUP NO HOLE W/HA 62MM GROUP 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9351727
• Report Number: 1038671-2019-00574
• Device Sequence Number: 11476144
• Product Code: JDI
• UDI-Device Identifier: 10885862037381
• UDI-Public: 10885862037381
• 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: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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 Model Number: 180-10-62
• Device Catalogue Number: 180-10-62
• Device Lot Number: 10160260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 09/05/2020
• 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: 77 YR
• Patient Weight: 49