MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 3; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX3SS
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision reverse total shoulder arthroplasty was performed following a patient dislocation.The surgeon determined a taller insert was required to address the instability.During removal of the existing insert, the humeral stem became loose.Consequently, the surgeon elected to revise both components, implanting larger perform reverse shoulder implants to restore stability and fixation.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a revision reverse total shoulder arthroplasty was performed following a patient dislocation.The surgeon determined a taller insert was required to address the instability.During removal of the existing insert, the humeral stem became loose.Consequently, the surgeon elected to revise both components, implanting larger perform reverse shoulder implants to restore stability and fixation.
Additional Manufacturer Narrative
The reported event was not confirmed even though the devices were returned for evaluation.However, no other evidence was provided in the form of x-rays or medical scans to confirm the alleged dislocation.The device inspection revealed the following: the returned stem shows little signs of wear and has no signs of used bone cement or any organic growth withing the porous titanium coating at the neck of the implant.A functional inspection was not possible nor deemed necessary.The returned implants appear in good functional shape with little to no signs of wear.Additionally, no evidence of the dislocation was provided by the reporter to confirm the functionality of the im-plants or the reported failure mode.A dimensional inspection of the returned device was not considered necessary.How-ever, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause could not be determined.No other evidence of the alleged event other than the returned devices was provided.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 more information is provided, the case will be reassessed.

• Brand Name: PERFORM HUMERAL STEM SZ 3
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22560914
• Report Number: 0001649390-2025-00533
• Device Sequence Number: 21214615
• Product Code: PAO
• UDI-Device Identifier: 00846832085477
• UDI-Public: (01)00846832085477(11)240808(17)290808(21)AH5041024
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: DWX3SS
• Device Lot Number: AH5041024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG