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

Catalog Number	164-01-11
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	02/13/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices 2424094 130-32-51 - nv gxl liner neutral, 32mm id group 1 cups 2133472 180-01-50 - nv crown cup clstr hole 50mm group 1 2374123 170-32-00 - biolox delta femoral head 32mm od, +0mm 2560510 122-65-30 - 6.5mm acetabular bone screw 30mm.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a 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 135 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, severe pain; severe osteolysis, excessive soft tissue debris consistent with synovitis, grossly loose femoral stem, loose cup, excessive polyethylene wear on liner with signs of oxidation / yellow discoloration, pitting, cracking, and delamination.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear and osteolysis may have been 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).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.H6: corrected component, and investigation clinical codes.

• Brand Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20170301
• Report Number: 1038671-2024-03370
• Device Sequence Number: 7002930
• Product Code: JDI
• UDI-Device Identifier: 10885862035097
• UDI-Public: 10885862035097
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 11/07/2017
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 03/12/2025
• Date Device Manufactured: 11/09/2012
• 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 Sex: Female