MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-36-52
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Loss of Range of Motion (2032); Anxiety (2328); Osteolysis (2377); Implant Pain (4561)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 79 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, limited rom, loss of mobility, anxiety, emotional distress.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Concomitant devices: (2093034) 180-01-54 - nv crown cup clstr hole 54mm group 2 (2096380) 164-01-13 - element-stem, collarless w/ha, std offset, sz 13 (2126069) 120-65-30 - bone screw 6.5mm dia x 30mm long (2133880) 142-36-00 - cocr fem head 36mm +0 offset 12/14 the product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The most likely underlying cause for the revision reported in is a combination of risk factors specified in such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential), wear of the femoral head, and loss of range of motion.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.
Additional Manufacturer Narrative
Additional information fields: a2, a4, b5, b7, h6 clinical code.Corrected fields: h6: investigation codes.
Event or Problem Description
It was reported that approximately 79 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, limited rom, loss of mobility, anxiety and emotional distress due to right hip failure with pseudotumor in acetabulum.Revision operative reports were provided.Intraoperatively, the surgeon observed a large acetabular cavitary cyst.Upon dislocating the hip, the femoral stem was found to be stable with minimal erosion on the anterior and posterior aspects of the femur.The medial calcar neck and trochanteric regions were noted as quite solid and stable and therefore left intact.The polyethylene insert was worn posterior superiorly with polyethylene wear debris.The patient was revised to exactech devices.The surgeon noted that this case required a more extensive approach, including difficulty in retraction and placement of the components, no further issues or complications were reported.No additional information is available.

• Brand Name: NV GXL LNR, +5LAT, 36MM G2-52/54MM 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19479696
• Report Number: 1038671-2024-01817
• Device Sequence Number: 6988987
• Product Code: JDI
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• 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: 2011
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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: 03/31/2014
• Device Catalogue Number: 136-36-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 12/11/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 12/11/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2010
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 132 KG