MAUDE Adverse Event Report: OSTEOMED HEMI GREAT TOE IMPLANT; HEMI GREAT TOE IMPLANT, SMALL

Model Number	375-0002
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Pain (1994); Swelling (2091)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Following the surgical procedure, the patient complained of swelling, pain at the site, and experienced fever.Cultures did not show any infection, but the physician prescribed antibiotics.
Additional Manufacturer Narrative
The small, hemi great toe implant was not returned.It was kept by the patient after explantation.The implant surgery was 04/19/19, and the explant surgery was 05/17/19.The complaint concerns a patient's complaint of swelling at the site, and fever.At the time of explant, there were no signs of infection.Review of the dhr did not identify any non-conformance's associated with lot release.A two-year review did not identify any capas related to this instrument.A two-year review of the ncr database only found one, which was unrelated.This is the only complaint for this issue in two years.This implant is a part of the hemi 1st mpj "great toe" implant system (hemi).The hemi risk document includes an assessment of this failure mode.The predicted severity rating is a 3.Per the risk manament procedure, this corresponds with a "serious" severity level (results in injury or impairment requiring professional medical intervention).The final predicted risk level is "low".The hemi instructions for use (ifu) states, "the osteomed 1st mpj hemi implant system is comprised of implants made from cobalt chromium (astm f-799)." the ifu also states use of implants in this system is contraindicated "in patients previously sensitized to the implant material".This issue will be monitored through routine trending.

• Brand Name: HEMI GREAT TOE IMPLANT
• Common Device Name: HEMI GREAT TOE IMPLANT, SMALL
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8691793
• Report Number: 2027754-2019-00009
• Device Sequence Number: 2286844
• Product Code: KWD
• UDI-Device Identifier: 00845694011754
• UDI-Public: (01)00845694011754(10)1131134(30)1(17)221019
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K073065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 375-0002
• Device Catalogue Number: 375-0002
• Device Lot Number: 1131134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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
• Patient Age: 63 YR