MAUDE Adverse Event Report: EXACTECH, INC. NOVATION ELEMENT RO S/O COL SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	164-13-12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a patient is scheduled for a hip revision for an unknown reason.Per images received it was noticed that patient experienced prosthesis wear and loosening of femoral stem.X-ray and image received.The devices are not available for evaluation.No other information provided.Related to 1038671-2024-02068.
Additional Manufacturer Narrative
Pending investigation.D10: integrip cc, cluster 52mm (cat# 186-01-52 / serial# (b)(6)); biolox delta femoral head 32mm od, -3.5mm (cat# 170-32-93 / serial# (b)(6)).
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: NOVATION ELEMENT RO S/O COL SZ 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 19591773
• Report Number: 1038671-2024-02069
• Device Sequence Number: 8525153
• Product Code: MEH
• UDI-Device Identifier: 10885862202703
• UDI-Public: 10885862202703
• Combination Product (Y/N): N
• PMA/510(K) Number: K113320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2021
• Device Catalogue Number: 164-13-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• 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.
• Patient Sex: Unknown