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

Model Number 101-00-002

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Arthralgia (2355); Impaired Healing (2378)

Event Date 09/17/2018

Event Type  Injury  

Event Description

It was reported by a sales representative that the patient who was implanted with a 101-00-002 (3s hemi medium implant) revisited the surgeon for a check-up approximately 3 years post surgery due to pain at the surgical site.Post-assessment of x-rays taken, the surgeon confirmed a shift of the implant on the plantar aspect wherein resulted in a significant shortening of the hallux.At the time of the visit, the surgeon believed further shifting may occur and that removal is necessary to alleviate further shifting/shortening of the hallux.Dhr review was not conducted on the 3s hemi medium implant, 101-00-002, as the lot number is unknown.A review of the x-rays provided x-rays upon initial implantation and the re-visit were completed.X-rays were received of initial implantation and at the visit (b)(6) 2018.After review, it was noted that the implant was not seated flush with the bone as specified in labeling.The hallux was also noted to be lifting up.Bone resorption may also have occurred as the proximal phalanx appears shorter in length than in initial x-rays.The x-rays during the re-visit confirmed the implant has shifted on the plantar aspect.The surgeon plans to remove the implant.No known surgery has occurred to-date.If additional details that would impact the conclusion of this report are reported to trilliant surgical, a supplemental report shall be submitted.

Event Description

At facility x on (b)(6) 2018, a trilliant sales representative was notified of a 3s hemi implant, medium, non-sterile (101-00-002) that caused a 71-year old-female patient pain.It was noted that there was noticeable angulation.The original implantation of this 3s hemi implant, medium, non-sterile (101-00-002) was on (b)(6) 2015.The patient came in on (b)(6) 2018 for further review of the pain at the surgical site.Upon doctor 1's assessment of the x-rays, he noted that the implant had shifted on the plantar aspect.According to doctor 1, this shift correlated with the significant shortening of the hallux.Doctor 1 believed that the implant may still shift and he concluded a complete removal will be necessary within the next few weeks.

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 1-12 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.2.Date of event (b3) unknown.The event is considered to be onset of patient pain due to implant shift.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.Lot # and unique identifier (udi) # (d4) could not be confirmed.See possibilities in "additional investigation" section below.6.Explanted date (d7) not reported despite doctor stating that a removal surgery shall be required.Doctor or sales representative did not provide follow-up information.7.Reprocessor name and address (d9) n/a to this report.8.Concomitant medical products and therapy dates (d11) not reported.9.Device manufacture date (h4) could not be confirmed.See possibilities in "additional investigation" section below.10.Section h7 n/a to this report.11.Section h9 n/a to this report.Corrected information provided in follow-up submission b5 - description of event/problem for initial submission - corrected to reflect the information as reported in the internal complaint file and to not identify and physician or facility by name.E1 - initial reporter and contact/facility information edited to be for the doctor who reported the event to the sales representative.Contact information for sales representative is removed.G3 - report source added selection for health professional.H6 - patient code (2378 added), device code (4003 added), method code (4112 added), conclusion code (67 deleted, 4315 added).H10 - corrected data additional information provided in follow-up submission: g1 - contact name, telephone, and email updated as different personnel is submitting follow-up report 1 than submitted the initial submission.Investigation summary: the 3s medium hemi implant associated with this event was not returned for investigation as the implant still remains in the patient.As a result, the investigation of this event is limited to surgical review and a review of similar complaints in an effort to establish a root cause.Visual/dimensional inspection: no visual or dimensional inspection was performed as the implant associated with this event remains in the patient.Surgical technique review: the patient revisited the surgeon for a check-up approximately three (3) years post-surgery due to pain at the surgical site.Post assessment of the x-rays, the surgeon confirmed a shift of the implant on the plantar aspect which resulted in a significant shortening of the hallux.At the time of the visit, the surgeon believed further shifting may occur and a removal is necessary to alleviate further shifting / shortening of the hallux.The surgical technique of the implantation was not reviewed due to no details provided as the surgery took place approximately three (3) years ago.However, a review of the provided x-rays upon initial implantation and the re-visit were completed in efforts to identify the root cause of this event.Due to the limited information provided for this case, there are several contributing factors that could have resulted in the event reported.1.In review of the dorsal x-ray upon initial implantation, the implant was not seated flush with the bone as specified in ifu 900-01-009 rev.I section 9.This is determined by the gap observed between the implant and proximal phalanx.2.In review of the dorsal x-ray upon re-visit, it appears bone resorption could play a factor in the shortening of the hallux as the proximal phalanx appears much shorter in length than the initial x-ray.(note: the angle in which the x-rays were taken could affect the scale appearance.) 3.Additionally, both dorsal and lateral view of x-rays upon re-visit confirmed the implant has shifted on the plantar aspect.The plantar shift of the implant could also play a factor in the deformation of the hallux (i.E.Lifting up).There is a potential that the shift in the plantar aspect resulted in a gap to exist between the implant and the proximal phalanx causing the hallux to deform (i.E.Lift up).4.If a broach was utilized during the implantation surgery, there is a potential that, if the surgeon over-broached the bone, it caused the implant to have additional room to shift post-operatively.5.Patient's anatomy (bone quality and or existing conditions).In conclusion, no definitive root cause can be determined based on the information provided.The surgeon plans to remove the implant.Pcr/per log review: upon review of the complaint log, there is only one (1) complaint aside from this event associated with a 3s hemi implant.Conclusion: the complaint was confirmed by review of the provided x-ray.As discussed in the surgical technique review section, there are several contributing factors that could have resulted in the reported event; however, none can be definitively determined due to limited details provided.Review of the complaint log revealed one (1) other similar event.Based on the above investigation, no other actions is deemed necessary at this time.Additional investigation conducted 04/01/2020: lot numbers were identified as possbilties for the applicable 3s hemi implant, medium, non-sterile involved in this event up until the case date, 10/20/2015.The corresponding device history records (dhrs) were reviewed for any significant events (i.E.Nonconformances (ncrs), reworks (rwks), deviations) that may correlate to the reported event.1.Lot tsl000457, udi (b)(4), manufactured 11/13/2013] - no ncrs or rwks, one (1) deviation (discussed below).2.Lot 24734, udi (b)(4), manufactured 01/10/2014] - no ncrs, rwks, or deviations.3.Lot tsl001155, udi (b)(4), manufactured 05/28/2014] - no ncrs, rwks, or deviations.4.Lot tsl001163, udi (b)(4), manufactured 06/12/2014] - no ncrs, rwks, or deviations.5.Lot 26932, udi (b)(4), manufactured 01/05/2015] - no ncrs, rwks, or deviations.6.Lot 27074, udi (b)(4), manufactured 03/23/2015] - no ncrs, rwks, or deviations.Within the dhr of the lot tsl000457, a deviation was requested to substitute the implant material with astm f1537 instead of astm f75.The justification was made based on the materials having equivalent compositions and the substitute having the same or better mechanical properties.The material change would not affect the device performance or biocompatibility.Thus, the deviation does not correlate to the reported event of the implant shifting.As a result of the dhr review, it is concluded that no significant events were identified to correlate to the reported event.

• 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.; suite 100; houston TX 77007
• MDR Report Key: 8035495
• MDR Text Key: 126068379
• Report Number: 3007420745-2018-00016
• Device Sequence Number: 1
• Product Code: KWD
• UDI-Device Identifier: 00812926020082
• UDI-Public: 00812926020082
• Combination Product (y/n): N
• PMA/PMN Number: K072922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101-00-002
• Device Lot Number: SEE SECTION H10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR