MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-53
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Malunion of Bone (4529); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Related: mfr# 1038671-2023-01725 report 1 of 2.H11.Additional manufacturer narrative- report 2 of 2.D10.Concomitants: 3740653, 120-65-15 - bone screw 6.5mm dia x 15mm long.3655867, 120-65-20 - bone screw 6.5mm dia x 20mm long.3634907, 120-65-30 - bone screw 6.5mm dia x 30mm long.2828589, 160-01-13 - pf stem tapered plasma ext offset sz 132710634, 142-36-93 - cocr fem head 36mm -3.5 offset 12/14.3709576, 180-01-56 - nv crown cup clstr hole 56mm.Group 3.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement and then approximately 8 months after the initial procedure the patient had a left hip revision.Revision op report noted that the patient's total hip arthroplasty was complicated by a fracture of the femoral shaft which essentially healed in a malunion with subsidence of the stem and obvious loosening to the acetabulum.The surgeon noted that the stem was grossly unstable, however, they did not see any actual failure of the stem such as a fracture.There were multiple scuffs with the polyethylene, which was removed.Inspection of the patient's femur did not find any instability with palpation of the greater trochanter, nor any definite acute fracture lines.It was noted that the patient had a previous fracture which appeared to be healed on x-rays.However, there was widening in the metaphyseal region.The fracture had been low, almost exiting near the tip of the stem; it was just proximal to the tip of the stem.No surgical complications.Patient outcome was not reported.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h4, h6.Mdr section codes updated/corrected: a, b, c, d, e.The most likely underlying cause for the revision reported is prosthesis wear, instability, subsidence, and femoral stem loosening and a combination of risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) ".However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19927433
• Report Number: 1038671-2024-02718
• Device Sequence Number: 2797744
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2019
• Device Catalogue Number: 132-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 98 KG