MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP

Model Number	138-32-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation noted on (b)(6) 2019 this patient had a second revision surgery.This revision was due to the patient woke up in his bed and his hip was dislocated.The surgeon decided to remove the liner and head and put the same liner back in with a +10 head in to give the patient more leg length.This made the patient stable.The patient left the operating room in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned to exactech.In a review of the labeling and ifu 700-096-004 rev.N, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses, and follow the written instructions of the physician with respect to follow-up care and treatment.Upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event is patient condition.Concomitant medical device(s): pf spline plasma w/ha ext offset sz 10 (cat# 160-31-10, sn# (b)(4)).Bone screw 6.5mm dia x 20mm long (cat# 120-65-20, sn# (b)(4)).Cocr fem head 36mm +0 offset 12/14 (cat# 142-36-00, sn# (b)(4)).Nv crown cup clstr hole 52mm group 2 (cat# 180-01-52, sn# (b)(4)).
Event or Problem Description
As reported, a (b)(6) y/o female patient has an exactech right hip implanted in (b)(6) on (b)(6) 2011.The cup will be revised with the possibility of a total revision, only femoral heads would be needed for the scheduled revision.X-rays were sent for analysis.Proper instrumentation, and implants were ordered and sent to the hospital.Surgeon requested ceramic femoral head implants.During the case, there was an extensive amount of metallosis, the cup and stem were determined to be very loose.All implants were removed, and competitor¿s device was implanted as planned.Devices will not be returned per hospital policy.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation pending.(d11) concomitant device(s): pf spline plasma w/ha ext offset sz 10 (cat# 160-31-10, sn#: (b)(6)).Bone screw 6.5mm dia x 20mm long (cat# 120-65-20, sn#: (b)(6)).Cocr fem head 36mm +0 offset 12/14 (cat# 142-36-00, sn#: (b)(6)).Nv crown cup clstr hole 52mm group 2 (cat# 180-01-52, sn#: (b)(6)).No information provided in the following section(s): a4, a5, and b6.Section h11: correction made to h3.The other was written in error, please disregard.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported may have been the result of edge loading/impingement, patient condition, or a combination, which led to full thickness polyethylene wear and subsequent metallosis and loosening of the implants from the bone.However, this cannot be confirmed due to the devices not being returned.(d11) concomitant device(s): pf spline plasma w/ha ext offset sz 10 (cat# 160-31-10, (b)(6).Bone screw 6.5mm dia x 20mm long (cat# 120-65-20, (b)(6).Cocr fem head 36mm +0 offset 12/14 (cat# 142-36-00, (b)(6).Nv crown cup clstr hole 52mm group 2 (cat# 180-01-52, (b)(6).

• Brand Name: NOVATION
• Common Device Name: NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9626955
• Report Number: 1038671-2020-00014
• Device Sequence Number: 11483558
• Product Code: JDI
• UDI-Device Identifier: 10885862024749
• UDI-Public: 10885862024749
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2020

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: 09/22/2012
• Device Model Number: 138-32-52
• Device Catalogue Number: 138-36-52
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020; 03/25/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 01/24/2020; 04/15/2020
• 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: 44 YR