MAUDE Adverse Event Report: EXACTECH, INC. PF STEM TAPERED PLASMA EXT OFFSET SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Malunion of Bone (4529); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Insufficient Information (4580); 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
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.2710634 142-36-93 - cocr fem head 36mm -3.5 offset 12/14.2828589 160-01-13 - pf stem tapered plasma ext offset sz 13.3709576 180-01-56 - nv crown cup clstr hole 56mm group 3.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement on (b)(6) 2014.Approximately 8 months after the initial procedure the patient had a left hip revision on (b)(6) 2015.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement on (b)(6) 2014 due to painful end stage arthritis of left hip.Approximately 8 months after the initial procedure the patient had a left hip revision on (b)(6) 2015.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.
Additional Manufacturer Narrative
Added info to e4.D10.Concomitants: (b)(6) 120-65-15 - bone screw 6.5mm dia x 15mm long.(b)(6) 120-65-20 - bone screw 6.5mm dia x 20mm long.(b)(6) 120-65-30 - bone screw 6.5mm dia x 30mm long.(b)(6) 132-36-53 - nv gxl lnr, lipped, 36mm id, group 3 cups.(b)(6) 160-01-13 - pf stem tapered plasma ext offset sz 13.(b)(6) 180-01-56 - nv crown cup clstr hole 56mm group 3.Further information and/or investigation results will be provided within 30 days.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the revision reported was likely the result of an insufficient bond between the femoral stem and the bone, which led to aseptic (non-infected) femoral stem loosening.The loosening may have been related to the healed femur fracture reportedly observed by the surgeon.However, this cannot be confirmed as the device was not available for evaluation and no images or radiographs were provided.
Additional Manufacturer Narrative
H10.Related: mfr#1038671-2024-02718 report 2 of 2.H11.Additional manufacturer narrative- report 1 of 2.Additional information added.D1 and d4- correction, the device being reported is the femoral stem.These devices are used for treatment not diagnosis.There is no additional information available.
Event or Problem Description
No complications.Patient outcome was not reported.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: d4, h6 mdr section codes updated/corrected: a, 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: PF STEM TAPERED PLASMA EXT OFFSET SZ 13
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17364023
• Report Number: 1038671-2023-01725
• Device Sequence Number: 14969602
• Product Code: JDI
• UDI-Device Identifier: 10885862031808
• UDI-Public: 10885862031808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042842
• 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,Followup,Followup,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
• Device Catalogue Number: 160-01-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 07/09/2024; 08/07/2024; 01/31/2025
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/28/2023; 07/26/2024; 08/07/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 98 KG