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

Model Number	ARS655101
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
An accident involving a patient who had a tornier aequalis reverse right shoulder prosthesis implanted.Specifically, the patient was operated on again after suffering pain and after radiographic control for mechanical fracture of the humeral prosthetic stem (broken humeral body on the tightening screw between body and stem, no tightening of the assembly screw connecting screw.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint 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 further information is provided, the complaint report will be reassessed.
Event or Problem Description
An accident involving a patient who had a tornier aequalis reverse right shoulder prosthesis implanted.Specifically, the patient was operated on again after suffering pain and after radiographic control for mechanical fracture of the humeral prosthetic stem (broken humeral body on the tightening screw between body and stem, no tightening of the assembly screw connecting screw.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14660656
• Report Number: 0001649390-2022-00021
• Device Sequence Number: 5894274
• Product Code: KWS
• UDI-Device Identifier: 00846832069408
• UDI-Public: 00846832069408
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 04/24/2025
• Device Model Number: ARS655101
• Device Catalogue Number: ARS655101
• Device Lot Number: AZ3319303104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown