MAUDE Adverse Event Report: EXACTECH, INC. ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 8
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: bone screw 6.5mm dia x 20mm long (cat# 120-65-20 / serial# (b)(4)).Cocr fem head 32mm +3.5 offset 12/14 (cat# 142-32-03 / serial# (b)(4)).Nv gxl liner neutral, 32mm id group 1 cups (cat# 130-32-51 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 7.5 years post initial right tha, the female patient was brought back for right hip pain.Signs of osteolysis and a loose stem.The hip was dislocated, the femoral head removed, stem checked found loose and removed.Attention turned to cup.Liner was removed with a chisel, the bone screw was removed.The cup was checked and found to be well fixed.A new xle liner was implanted along with a hps stem.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device is not available for evaluation as patient asked to keep implants.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3 the revision reported was likely the result of an insufficient bond between the femoral stem and the femoral bone, which led to the reported pain and signs of osteolysis.However, this cannot be confirmed because the revised components were not returned for evaluation and only one image and one radiograph were provided.The most probable root cause associated with the reported event of ¿loosening - femoral stem¿ is associated with weakened integration of the femoral stem at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 8
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14545126
• Report Number: 1038671-2022-00627
• Device Sequence Number: 6568585
• Product Code: JDI
• UDI-Device Identifier: 10885862035288
• UDI-Public: 10885862035288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 09/02/2018
• Device Model Number: ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 8
• Device Catalogue Number: 164-03-08
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female