MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY 11DIA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	ARS741702
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the physician alleged that during the initial procedure the physician left too much stem exposed without placing some sort of bone strut on the initial surgery.Without bone to share the load with, the forces on the exposed humeral stem were too great and caused the assembly screw to break and the proximal body to rotate.The patient underwent a revision surgery because the assembly screw sheared off, causing the proximal body to rotate 180° and the patient to dislocate.
Additional Manufacturer Narrative
The reported event could be confirmed, since x-rays were provided for evaluation.A review of the x-rays by the medical expert confirmed the alleged failure.The device inspection was not possible as the product was not returned for investigation.The opinion of the medical expert was requested and stated as following: " the insufficient support of the device because of a lack of proximal bone fixation has jeopardized this implant.The forces on an unsupported modular implant will eventually lead to failure of the device.However, with only one x-ray available it cannot be assessed whether the insufficient bone support was there at the time of implantation, or that it is a result of bone resorption." the device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More information as well as the affected device must be available in order to determine if the root cause of the alleged failure is user-related or patient-related or a combination of factors.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 physician alleged that during the initial procedure the physician left too much stem exposed without placing some sort of bone strut on the initial surgery.Without bone to share the load with, the forces on the exposed humeral stem were too great and caused the assembly screw to break and the proximal body to rotate.The patient underwent a revision surgery because the assembly screw sheared off, causing the proximal body to rotate 180° and the patient to dislocate.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY 11DIA
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16739788
• Report Number: 0001649390-2023-00051
• Device Sequence Number: 12423804
• Product Code: KWS
• UDI-Device Identifier: 00846832069293
• UDI-Public: 00846832069293
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: ARS741702
• Device Catalogue Number: ARS741702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown