MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI HUM HEADSIZE 4 1X15; PROSTHESIS, TOTAL ANATOMICAL SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Catalog Number	7122869
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent left primary anatomic shoulder replacement for primary implants.Over recent months patient has been complaining of increasing pain and instability in this shoulder joint, suspected rotator cuff failure.Decision made intra-operatively to remove all primary implants, and convert this prosthetic joint to a reverse shoulder replacement.Both the tornier simpliciti humeral components, and the perform pegged glenoid component.Negligible bone was lost during this part of the surgery.The revision components implanted were from competitor (enovis / djo).
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed as the device was not returned for evaluation and no additional information was available.The available picture indicates broken component but is not sufficient to perform the detailed inspection.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material or manufacturing related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any further information is provided the complaint report will be updated.
Event or Problem Description
Patient underwent left primary anatomic shoulder replacement for primary implants.Over recent months patient has been complaining of increasing pain and instability in this shoulder joint, suspected rotator cuff failure.Decision made intra-operatively to remove all primary implants, and convert this prosthetic joint to a reverse shoulder replacement.Both the tornier simpliciti humeral components, and the perform pegged glenoid component.Negligible bone was lost during this part of the surgery.The revision components implanted were from competitor (enovis / djo).

• Brand Name: TORNIER SIMPLICITI HUM HEADSIZE 4 1X15
• Common Device Name: PROSTHESIS, TOTAL ANATOMICAL SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22055973
• Report Number: 0001649390-2025-00327
• Device Sequence Number: 14480567
• Product Code: PKC
• UDI-Device Identifier: 00846832004836
• UDI-Public: (01)00846832004836(17)230313(21)5386AT030
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 03/13/2023
• Device Catalogue Number: 7122869
• Device Lot Number: 5386AT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2018
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 78 KG