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

Model Number	ARS655102
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a shoulder surgery.Sometime post-op the locking cap/assembly screw failed causing the prosthesis to disassemble in-situ.The patient will need to undergo a revision procedure to correct the problem.
Additional Manufacturer Narrative
The reported event was confirmed by x-rays provided for evaluation.A device inspection was not possible since the affected device was not returned.The medical opinion of a medical expert was requested to evaluate the risk of this event: ¿there may be factors contributing to this event.First, there is no bone support for the stem proximal to the junction between the distal border of the spacer and the proximal border of the distal stem.The cement mantle is just below this junction.Second, axial rotational forces will be transmitted via the proximal body, and the fact that the distal stem is fixed in the cement in the humerus, and the rest of the assembly is not, may be a factor that contributed to this event.¿ 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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient underwent a shoulder surgery.Sometime post-op the locking cap/assembly screw failed causing the prosthesis to disassemble in-situ.The patient will need to undergo a revision procedure to correct the problem.Update: the patient had low activity level.The t20 screwdriver was used first followed by using the t20 driver bit and torque limiting handle to complete the assembly of the prosthesis.Info not available when patient was made aware of failure.No remarkable circumstances were present when used.The revive humeral was used because of a fracture to the proximal humerus.

• 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: 11888668
• Report Number: 3004983210-2021-00048
• Device Sequence Number: 14360744
• Product Code: KWS
• UDI-Device Identifier: 00846832069415
• UDI-Public: 00846832069415
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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 Expiration Date: 06/08/2025
• Device Model Number: ARS655102
• Device Catalogue Number: ARS655102
• Device Lot Number: AZ1220072030
• 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: 05/03/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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: Male