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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) 180-01-48 - nv crown cup clstr hole 48mm group 1.
Event or Problem Description
Approximately 12 years 7 months after right primary total hip replacement, the patient returned complaining of pain and dissatisfaction with their left primary hip.The poly and a recalled implant were worn upon examination and imaging.The patient underwent revision left tha on (b)(6) 2024 where the stem, head, and liner were removed.A new liner was implanted into the cup and a different company (stryker) stem and the head was implanted into the femoral side.This event is not related to the breakage of a device.The event did not lead to a surgical prolongation/delay.Patient was last known to be in stable condition following the event.Product not returning: implants are sent to the lab and legal.Not given to the representative.Unable to obtain images of explants or x-rays.Images & ebi attached.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-02129, 1038671-2024-02130.This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is 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) and being implanted for more than 10 years.However, this cannot be confirmed from the reported information and the devices were not available for.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19776382
• Report Number: 1038671-2024-02443
• Device Sequence Number: 12925357
• Product Code: MEH
• UDI-Device Identifier: 10885862035097
• UDI-Public: 10885862035097
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2016
• Device Catalogue Number: 164-01-11
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2011
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male