MAUDE Adverse Event Report: EXACTECH, INC. NV CEMENTED PLUS STD SIZE 15; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	160-70-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	11/26/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 180-01-56 - nv crown cup clstr hole 56mm group 3: (b)(6), 122-65-30 - 6.5mm acetabular bone screw 30mm: (b)(6), 138-36-53 - nv gxl lnr, 10 deg face, 36mm id, grp 3 cup: (b)(6), 142-36-00 - cocr fem head 36mm +0 offset 12/14: (b)(6), 160-70-15 - nv cemented plus std size 15: (b)(6), pc-15 - stem centralizer 15mm: (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total hip replacement on the right side.Approximately 48 months post-operatively, the patient was putting on his pajamas when his right leg got caught in them, causing him to lose his balance and fall on his right hip.This resulted in a right periprosthetic femur fracture, which was treated with open reduction internal fixation and medication.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A review of complaint history determined that no further action is required as no trends were identified.The reason for the surgery reported was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition or a traumatic event.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV CEMENTED PLUS STD SIZE 15
• 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
• MDR Report Key: 22699639
• Report Number: 1038671-2025-02668
• Device Sequence Number: 8944701
• Product Code: JDI
• UDI-Device Identifier: 10885862033086
• UDI-Public: 10885862033086
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K083392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 08/08/2015
• Device Catalogue Number: 160-70-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2010
• 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: Hospitalization
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White