MAUDE Adverse Event Report: TORNIER INC PERFORM 45% INSERT SZ3/4 36 MM +0; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWP2360
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/18/2026
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 conducted on (b)(6) 2025.Later, he felt looseness in his shoulder joint when going to bed.Partial revision arthroplasty was conducted on (b)(6) 2026 due to instability, although no dislocation was present.No further information was provided.
Event or Problem Description
It was reported that; the primary surgery was conducted on (b)(6) 2025.Later, he felt looseness in his shoulder joint when going to bed.Partial revision arthroplasty was conducted on (b)(6) 2026 due to instability, although no dislocation was present.No further information was provided.
Additional Manufacturer Narrative
Correction- d3 (manufacturer entity was corrected from tornier sas to tornier inc.) the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided 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 the device is returned or if any further information is provided the complaint report will be updated.

• Brand Name: PERFORM 45% INSERT SZ3/4 36 MM +0
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24640671
• Report Number: 0001649390-2026-00287
• Device Sequence Number: 18615683
• Product Code: KWS
• UDI-Device Identifier: 00846832084456
• UDI-Public: (01)00846832084456(11)240213(17)290213(10)AG7797020
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: DWP2360
• Device Lot Number: AG7797
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG