MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	ARS741813
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Allegedly, the patient underwent a surgical procedure on the shoulder.Approximately 6 months post-op it was found on x-ray that the stem is coming unscrewed in-situ.According to the surgeon the patient is very compliant just very active.The patient does not wish to undergo additional surgery at this time.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but few x-rays were shared which confirms the alleged failure.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.A few x-rays were provided which were presented to our health care professional for evaluation, question about most likely reason for disassociation of stem was asked, to which medical expert opined: ¿(b)(6) 2020: conversion of anatomic total shoulder (you see the 2markers of the uhmwpe glenoid) to revive stem placed as part of rtsa.(b)(6) 2020: follow-up x-ray 1 shows good position, proper assembly, suture staples in situ, still bone stock around the proximal part of the stem.(b)(6) 2021: follow-up x ray 3 shows suture staples removed, proper assembly of the stem, some bone resorption around the proximal part of the stem.(b)(6) 2021: follow-up x ray 9 shows progressive bone resorption and unscrewing of the revive stem (body and spacer) from the distal stem.Date unknown: follow-up x-ray of the revive proximal part and spacer, showing proper assembly, cement augmentation of the proximal humerus.There may be several factors contributing to this event.First, there is decreasing bone support for the stem proximal to the junction between the proximal border of the spacer and the distal border of the proximal body.Second, axial rotational forces will be transmitted via the proximal body, and the fact that the distal stem is well-fixed in the humerus, and the rest of the assembly is not, may be a factor that contributed to this event.In short, insufficient bone stock with insufficient support of the assembly proximal to junction with the spacer may have contributed to this event.The ifu notes the risk of insufficient bone stock as a relative contraindication for the use of this prothesis: rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.¿ the device must be available in order to determine the exact root cause of the failure.However, based on the available information and the opinion received from the health care professional, the most probable cause of the issue is most likely patient related.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text: device not available.
Event or Problem Description
Allegedly, the patient underwent a surgical procedure on the shoulder.Approximately 6 months post-op it was found on x-ray that the stem is coming unscrewed in-situ.According to the surgeon the patient is very compliant just very active.The patient does not wish to undergo additional surgery at this time.Update: hemi was taken out and perform reverse glenoid and revive humeral stem implanted.First post op shows that the glenosphere construct has shifted.Subsequent x-rays show disassociation of revive beginning.The doctor said the patient is normal size.Perform proximal body, spacer, locking cap and screw were removed from the patient.Surgeon decided to rebuild construct off original stem (well fixed) and so we left that in the patient.

• Brand Name: AEQUALIS FLEX REVIVE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 11918092
• Report Number: 3004983210-2021-00050
• Device Sequence Number: 3268865
• Product Code: KWS
• UDI-Device Identifier: 00846832074204
• UDI-Public: 00846832074204
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ARS741813
• Device Catalogue Number: ARS741813
• Device Lot Number: AZ0718288123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White