MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN TRAUMA & EXTREMITIES DEV; NAIL, FIXATION, BONE

Device Problems Fracture (1260); Material Fragmentation (1261); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Arthralgia (2355); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)

Event Date 12/28/2021

Event Type  Injury  

Event Description

It was reported that, eleven (11) months after an unknown implant had been placed on (b)(6) 2020 in the patient's second toe, the patient suddenly started experiencing pain and ambulatory difficulties.On (b)(6) 2021, an mri was taken and showed that there was something not right with the implant, so a ct was prescribed.On (b)(6) 2022 the ct was taken and showed that the screw (or its mechanism) appears to be coming out from the toe.This adverse event was addressed via revision surgery on (b)(6) 2022 to remove the silicone implant, which it was noticed to be fractured in two pieces.Fluoroscopy had to be used to locate the second piece.A spur was also found, which could be contributing to the pain.It is unknown how the patient's health condition has evolved since the intervention.

Manufacturer Narrative

H3, h6: the product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified no similar reported events for this device.No previous events or issues were identified for the same product lot.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file.As identifying details for the specific product associated with this complaint were not provided, the risk acceptability could not be assessed.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Medical investigation monitoring board (mimb) review: per mimb, a medical investigation was required.Clinical/medical evaluation: determined that the alleged failure was possibly related to the device, though other contributing factors were noted including patient¿s previous medical history and health status at the time of the failure.As the device has not been received for evaluation, a definitive root cause could not be determined.The complaint alleges that revision surgery was required.A determination of whether the device might have contributed to the reported event could not be made as the device has not been received for evaluation.Documentation provided by the customer indicated that the integra silicone toe device associated with this complaint was implanted following the revision of a previous toe joint replacement device from a different manufacturer (cartiva).The documentation indicates that the patient experienced dislocation of the previous implant, as well as "significant join destruction" and "significant adhesions to extensor tendons and surrounding soft tissue".The documentation also indicates that the patient has a medical history of concomitant conditions which may have contributed to the failure of the first and second devices, including osteoporosis.Insufficient information was available to make any further determination of the cause for the reported event.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

Manufacturer Narrative

H10: additional information added in b5 and h6 ((b)(6) was updated).

Event Description

It was reported that, eleven (11) months after an unknown implant had been placed on (b)(6) 2020 in the patient's second toe, the patient suddenly started experiencing pain and ambulatory difficulties.On (b)(6) 2021, an mri was taken and showed that there was something not right with the implant, as an intense marrow edema involving the second proximal phalanx and distal aspects of the second metatarsal phalangeal joint implant was present, so a ct was prescribed.On (b)(6) 2022 the ct was taken and showed a 1mm width lucency band surrounding the implant at the metatarsal side and a 2mm band surrounding the proximal phalanx side, along with cystic type changes surrounding the implant area.This adverse event was addressed via revision surgery on (b)(6) 2022 to remove the silicone implant, which it was noticed to be fractured in multiple pieces.The distal stem of the implant in the proximal phalanx was removed with great difficulty, and a sub-periosteal dissection was performed on the head neck of the second metatarsal.Under fluoroscopic guidance, the head of the second metatarsal was resected upon performing an osteotomy at the level of the metatarsal neck and was found to present substantial arthritic changes.It is unknown how the patient's health condition has evolved since the intervention.

Manufacturer Narrative

Updated results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified no similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.Identifying details for the specific product associated with this complaint were not provided, so the risk acceptability could not be determined.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Medical investigation monitoring board (mimb) review: per mimb, a medical investigation was required.Clinical/medical evaluation: determined that the alleged failure was possibly related to the device, though other contributing factors were noted including patient¿s previous medical history and health status at the time of the failure.The complaint alleges that revision surgery was required.As the device has not been received for evaluation, a definitive root cause could not be determined.As the device has not been received for evaluation, a determination of whether the device might have contributed to the reported event could not be made.As the product lot number was not reported, a determination of whether the device met manufacturing specifications could not be made.Documentation provided by the customer indicated that the integra silicone toe device associated with this complaint was implanted following the revision of a previous toe joint replacement device from a different manufacturer (cartiva).The documentation indicates that the patient experienced dislocation of the previous implant, as well as "significant join destruction" and "significant adhesions to extensor tendons and surrounding soft tissue".The documentation also indicates that the patient has a medical history of concomitant conditions which may have contributed to the failure of the first and second devices, including osteoporosis.The clinical/medical evaluation also identified the patient's previous medical history and health status as contributing causes for the reported event.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing deficiencies were identified.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: UNKN TRAUMA & EXTREMITIES DEV
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14291472
• MDR Text Key: 290925339
• Report Number: 3002788818-2022-00004
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female