MAUDE Adverse Event Report: EXACTECH, INC. ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	164-01-11
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 42 yo patient, who had tha¿s on both hips on different dates, underwent a revision procedure on the left hip approximately 1 year 9 months post the initial procedure.The reported information indicated there was notification of wear and tear and comprehensive follow-up for patients treated surgically and experiencing problems with the implanted materials.Hospitalization required, need for intervention to prevent injury or permanent disability, physical, emotional, social, and work-related impact was also reported.The report stated the acetabular component in both hips remains implanted.No device images or x-rays were provided.No further information.
Additional Manufacturer Narrative
D10: 01-034-05-5044, universal cup, pressfit, 3 covers, ha, 50mm - 44.01-033-03-4436, universal cup liner, delta, 44mm - 36.01-032-03-3694, universal cup, head, delta, 36mm, -4.01-034-05-4639, universal cup, pressfit, 3 covers, ha, 46mm - 39.01-033-03-3932, universal cup liner, delta, 39mm - 32.01-032-03-3294, universal cup, head, delta, 32mm, -4.01-032-03-3200, universal cup, head, delta, 32mm, +0.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.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.Information regarding the reason for the revision was not provided.Due to the limited information, this complaint event cannot be further investigated or confirmed, and a definitive cause, in addition to any potential product, patient, and/or user-related contributing factors cannot be definitively determined.There is no indication within the available information that a new or unexpected failure mode or harm/adverse event type has occurred or that the benefit-risk analysis for these products has been altered; therefore, no further risk analysis will be performed.However, this event will be included in complaint trending per qwi-000195 complaint trending and actions will be taken as required upon detection of any trend signals.No further action or escalation will be taken at this time concerning this reported event.Should additional relevant information be received concerning this event, the complaint investigation will be re-opened and actions will be taken as appropriate.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 24464409
• Report Number: 1038671-2026-00202
• Device Sequence Number: 10007835
• Product Code: MEH
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Catalogue Number: 164-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown