MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 38MM REVERSE LINER +0 S; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number LNR-0990-200-380S

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, after a shoulder surgery had been performed on (b)(6) 2023, patient experienced dislocation.During procedure, it was observed that the reverse liner was able to rock slightly in the stem and that it was severely deformed from the dislocation.This adverse event was addressed by revision surgery on (b)(6) 2024, to exchange the 38mm reverse liner +0 s.Patient's current health is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, this case reports that three months following implantation of the reverse liner a revision surgery was performed due to reportedly being ¿severely deformed from the dislocation.¿ the patient is a 51-year-old male.Per case details, the reverse liner was able to rock slightly in the stem and was exchanged during the revision.Three intraoperative photos were provided for review and confirm the deformation which appears to be the tract of the dislocated head.Based on the limited information provided the clinical root cause of the reported events could not be determined.We cannot rule out trauma or extreme motion or laxity within the joint.The patient impact beyond the reported revision could not be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for aetos shoulder system revealed in post operative section that postoperative patient care and directions and warnings to patients by physicians are extremely important.Normal daily activity may be resumed at the physician¿s direction.Also it is state in warning section that excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints tend to adversely affect shoulder replacement implants.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient condition, and/or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 38MM REVERSE LINER +0 S
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18977082
• MDR Text Key: 338551391
• Report Number: 3002788818-2024-00042
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00885556810170
• UDI-Public: 885556810170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Catalogue Number: LNR-0990-200-380S
• Device Lot Number: 700003703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male