MAUDE Adverse Event Report: TORNIER INC PERFORM 45% INSERT SZ1/2 39 MM +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1390
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, the primary surgery was performed on (b)(6) 2024.Approximately one year later, the patient visited the hospital due to suspected infection.Although the condition was initially managed with medication, 2nd surgery was performed in (b)(6) 2025 to reopen and irrigate the surgical site.Due to persistent infection, a 3rd surgery was performed on (b)(6) 2025.According to the surgeon, there was no loosening of the stem and baseplate fixed within the bone, and no signs of intramedullary infection.Therefore, only the external implant components¿the insert and sphere¿were removed.The wound was thoroughly irrigated using a brush, and new implants of the same size were reinserted before closing the surgical site.No further information was available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.No indications of material, manufacturing or design 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 device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that; the primary surgery was performed on (b)(6) 2024.Approximately one year later, the patient visited the hospital due to suspected infection.Also, the infection was discovered when the patient visited the hospital several months later due to pain.Although the condition was initially managed with medication, 2nd surgery was performed in (b)(6) 2025 to reopen and irrigate the surgical site.Due to persistent infection, a 3rd surgery was performed on (b)(6) 2025.According to the surgeon, there was no loosening of the stem and baseplate fixed within the bone, and no signs of intramedullary infection.Therefore, only the external implant components¿the insert and sphere¿were removed.The wound was thoroughly irrigated using a brush, and new implants of the same size were reinserted before closing the surgical site.No further information was available.

• Brand Name: PERFORM 45% INSERT SZ1/2 39 MM +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22795554
• Report Number: 0001649390-2025-00570
• Device Sequence Number: 12922424
• Product Code: PHX
• UDI-Device Identifier: 00846832084425
• UDI-Public: (01)00846832084425(11)230523(17)280523(21)7315AY009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Catalogue Number: DWP1390
• Device Lot Number: 7315AY
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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