MAUDE Adverse Event Report: TRILLIANT SURGICAL 3S HEMI IMPLANT, MEDIUM, NON-STERILE; 3S HEMI IMPLANT SYSTEM IMPLANT

Model Number 101-00-002

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)

Patient Problems Erythema (1840); Failure of Implant (1924); Pain (1994); Swelling (2091); Skin Inflammation (2443)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

An event was reported where a 3s hemi implant had "loosened" from the surgical site and was causing pain.The hemi was initially implanted on (b)(6) 2017 and a removal occurred on (b)(6) 2019.During the removal, "black smudge" was observed at the interface site between the implant and the bone.Parts were not returned and a lot number was not provided and only a limited investigation could be completed.A dhr review, visual inspection, dimensional inspection and simulated use testing were not able to be completed as parts were not returned and the lot number is unknown.A review of the surgical technique related to the initial implantation is not possible as no details were provided.The complaints log was reviewed for all 3s hemi implants and only 1 additional complaint was identified.Ccr (b)(4) involved a 101-00-002 implant which shifted from the surgical site, caused pain, and needed to be removed.No complaints identified black residue on the implant after removal.Due to the limited details provided, an isolated root cause was not able to be determined.No objective evidence of the discolored implant and material were provided and it is unknown what may have caused the "black smudge" described.(b)(6), the initial reporter, was contacted via phone 3 times (06/27/2019, 06/28/2019, and 07/02/2019) to attempt to gain additional details.No e-mail or address is available and written communication could therefore not be established.Applicable reporting requirements shall be completed and this investigation shall be closed.If additional details are provided at a later date, the investigation shall be re-opened and applicable reporting requirements satisfied.

Event Description

(b)(6) contacted trilliant surgical r&d engineer, (b)(4), on (b)(6) 2019 to determine the material composition of the 3s hemi implant because she believed she could possibly have had a patient with an allergy.Upon discovery of the nature of the phone call, chris transferred cassandra to sales support to ensure the information was documented.Dr.(b)(6) implanted a 3s hemi on (b)(6) 2017 at (b)(6) health in (b)(6).On (b)(6) 2019, the patient visited (b)(6) hospital (b)(6) with report of pain, redness, and swelling at the site.Dr.(b)(6) utilized x-rays to determine that the hemi implant had loosened.A removal case was scheduled for (b)(6) 2019.Dr.(b)(6) noted that there was "black smudge" upon opening the site, and the bone where the implant was placed had turned black.Dr.(b)(6) performed deep debridement utilizing a sonicone ultrasonic wound care system, and her plan is wait and see how the site heals.Dr.(b)(6) believes there is a possibility the patient's toe may need to be amputated.Sales support contacted the or to request the return of the removed hemi implant to corporate, but the implant had already been discarded.

Event Description

Initial event: (b)(6) contacted trilliant surgical r&d engineer, (b)(6) , on (b)(6) 2019 to determine the material composition of the 3s hemi implant because she believed she could possibly have had a patient with an allergy.Upon discovery of the nature of the phone call, chris transferred cassandra to sales support to ensure the information was documented.(b)(6) implanted a 3s hemi on (b)(6) 2017 at mercy health in (b)(6).On (b)(6) 2019, the patient visited (b)(6).With report of pain, redness, and swelling at the site.(b)(6) utilized x-rays to determine that the hemi implant had loosened.A removal case was scheduled for (b)(6) 2019.(b)(6) noted that there was "black mudge" upon opening the site, and the bone where the implant was placed had turned black.Dr.Wilson performed deep debridement utilizing a sonicone ultrasonic wound care system, and her plan is wait and see how the site heals.Dr.Wilson believes there is a possibility the patient's toe may need to be amputated.Sales support contacted the or to request the return of the removed hemi implant to corporate, but the implant had already been discarded.Follow up received (b)(6) 2019: on (b)(6) 2019 (b)(6) contacted trilliant surgical quality engineer kml and confirmed that the patient did have a infection (rare staphylococcus caprae).The patient is recovering and his toe is healing and will not need to be amputated.

Manufacturer Narrative

This is a follow up from previous complaint.No additional comments are necessary, this is the first complaint received where an infection developed for a 3s hemi implant.

Manufacturer Narrative

--notes to form 3500a and justification for information not provided (in initial or follow-up submission) as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-9 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.3.Catalog # and serial # (d4) not utilized by trilliant surgical.4.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.5.Reprocessor name and address (d9) n/a to this report.6.Concomitant medical products and therapy dates (d11) not reported.7.Initial reporter's occupation (e2, e3) is unknown.8.Section h9 n/a to this report.9.No files attached to this report.Corrected information provided in follow-up submission: b1 - adverse event and product problem are selected.B5 - description of event or problem was edited to not identify any physician or institution by name.D2 - common device name corrected, product code was correct in initial submission.D3 - fax number added.D4 - model #, catalog #, serial #, lot #, unique identifier (udi) #.Section f n/a to this report.G1, g2 - fax number added.G3 - other is selected, while company representative is deleted.Other is selected because the occupation/relationship of the initial reporter to the event cannot be confirmed.G4 - date received by manufacturer is changed to the date that the information from follow-up 1 was received.H10 - corrected data.Additional information provided in follow-up submission: g1 - name, email, telephone updated as different personnel is submitting the follow-up submission than submitted the initial submission.H10 - additional manufacturer narrative.Additional investigation conducted 03/20/2020: tsl003264 (part number 101-00-002) was identified as the lot number for this event as seen in section d4.The part / lot number was identified upon review of associated sales data.The corresponding dhr was reviewed for any significant events (i.E.Nonconformances (ncrs), reworks (rwks), deviations) that may correlate to the reported event.Nmr 15-324 was initiated for the sterile 3s hemi implants being expired and no longer maintaining sterility.The lot was reworked as all the parts met the same compositional and dimensional specifications as the non-sterile 3s hemi implants.Thus, the parts were utilized as non-sterile 3s hemi implants.Because the parts were cleaned and passivated, it likely does not correspond to the allergic reaction the patient was experiencing.As a result of the dhr review, it is concluded that there is no correlation to the reported event.

Event Description

Initial event (b)(6) 2019): cb contacted a trilliant surgical r&d engineer on (b)(6) 2019 to determine the material composition of the 3s hemi implant because she believed she could possibly have had a patient with an allergy.Upon discovery of the nature of the phone call, the r&d engineer transferred cb to sales support to ensure the information was documented.Doctor 1 implanted a 3s hemi implant on 06/13/2017 at facility x.On (b)(6) 2019, the patient visited facility y with report of pain, redness, and swelling at the site.Doctor 2 utilized x-rays to determine that the 3s hemi implant had loosened.A removal case was scheduled for (b)(6) 2019.Doctor 2 noted that there was "black mudge" upon opening the site and the bone where the implant was placed had turned black.Doctor 2 performed deep debridement utilizing a sonicone ultrasonic wound care system and her plan is wait and see how the site heals.Doctor 2 believes there is a possibility the patient's toe may need to be amputated.Sales support contacted the or to request the return of the removed 3s hemi implant to corporate, but the implant had already been discarded.Follow-up information (07/02/2019): on (b)(6) 2019, cb contacted a trilliant surgical quality engineer and confirmed that the patient did have an infection (rare staphylococcus caprae).The patient is recovering and his toe is healing and will not need to be amputated.

• Brand Name: 3S HEMI IMPLANT, MEDIUM, NON-STERILE
• Type of Device: 3S HEMI IMPLANT SYSTEM IMPLANT
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n shepherd dr; ste 100; houston TX 77007
• MDR Report Key: 8754262
• MDR Text Key: 149829364
• Report Number: 3007420745-2019-00035
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K072922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-00-002
• Device Lot Number: TSL003264
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 66 YR