MAUDE Adverse Event Report: EXACTECH, INC. ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	164-02-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 1304258 164-02-09 - element-stem, collarless w/ha, high offset, sz 9.2298767 142-32-00 - cocr fem head 32mm +0 offset 12/14.2436987 120-65-30 - bone screw 6.5mm dia x 30mm long.2441060 180-02-54 - nv cwn cup mlt hl 54mm group 2.The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was the cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 131 months after a right total hip replacement procedure, the patient underwent a revision procedure to address loosening, and pain.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Updated d2a, d4, d10, h6 d10: concomitant devices: (b)(6) 142-32-00 - cocr fem head 32mm +0 offset 12/14.(b)(6) 120-65-30 - bone screw 6.5mm dia x 30mm long.(b)(6) 180-02-54 - nv cwn cup mlt hl 54mm group 2.(b)(6) 130-32-52 - nv gxl linr, ntrl, 32mm id, group 2 cups.
Additional Manufacturer Narrative
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 evaluation.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, HIGH OFFSET, SZ 9
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19392071
• Report Number: 1038671-2024-01469
• Device Sequence Number: 7744022
• Product Code: JDI
• UDI-Device Identifier: 10885862035189
• UDI-Public: 10885862035189
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2025

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: 08/05/2013
• Device Catalogue Number: 164-02-09
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: Not provided; 02/03/2025
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/24/2024; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2008
• 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 H10.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown