MAUDE Adverse Event Report: EXACTECH, INC. ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products bsc-cup pf 3 hole closed ti/ha 52mm (cat#: 382-44-52 / serial#: (b)(4)).Xonit pe liner standard (cat#: 420-36-44 / serial#: (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the (b)(6) y/o male patient had undersized, varus stem that had become loose (aseptic).Surgeon removed the stem and cup and implanted a srom stem and zb g7 dual mobility cup.Patient was last known to be in stable condition following the event.The device is not for evaluation due to facility policy.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of wear of an insufficient bond between the implant and the bone due to implanting a femoral stem that was undersized compared to the patient¿s anatomy which led to aseptic (non-infected) loosening.However, this cannot be confirmed because the component was not returned for evaluation and x-rays were not provided.The most probable root cause associated with the reported event of "loosening - femoral stem" is associated with weakened integration of the device 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 10
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11446575
• Report Number: 1038671-2021-00099
• Device Sequence Number: 17147379
• Product Code: JDI
• UDI-Device Identifier: 10885862035301
• UDI-Public: 10885862035301
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 02/08/2017
• Device Model Number: ELEMENT-STEM, COLLARED W/HA, STD OFFSET, SZ 10
• Device Catalogue Number: 164-03-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 53 YR