MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; INTEGRIP CC, CLUSTER 48MM, G1

Model Number	186-01-48
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: (cn: 138-32-51, sn: (b)(4)) gxl liner 10 face changing +5 lateralize; (cn: 170-32-00, sn: (b)(4)) biolox femoral head.
Event or Problem Description
As reported, this (b)(6) y/o female was initially implanted on (b)(6) 2018.At follow up on (b)(6) 2018 in the office.The surgeon noticed an area that was not against bone.He followed it for couple years.Each time it continued to move and show more loosening.Approximately 2 yrs postop the initial implant, the surgeon revised to a competitor¿s revision multi hole cluster cup with a +10 lateralized liner and then used a +7 biolox head.Devices will not return as the surgeon kept them.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event reported was likely the result of aseptic loosening of the acetabular cup secondary to inadequate initial fixation and subsequent prosthesis wear of the polyethylene component from impingement.Concomitant device: (cn: 138-32-51, sn: (b)(6) gxl liner 10 face changing +5 lateralize.(cn: 170-32-00, sn: (b)(6) biolox femoral head.No information provided in the following section(s): a4, a5, b6 the following section(s) have additional info: g4, g7, h1, h2, h3, h7.

• Brand Name: NOVATION
• Common Device Name: INTEGRIP CC, CLUSTER 48MM, G1
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10696377
• Report Number: 1038671-2020-00581
• Device Sequence Number: 19794700
• Product Code: JDI
• UDI-Device Identifier: 10885862038753
• UDI-Public: 10885862038753
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 186-01-48
• Device Catalogue Number: 186-01-48
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 73