MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 2 PLUS; SEMI-CONSTRAINED METAL CEMENTED SHOULDER PROSTHESIS

Model Number	DWX2PS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
The poly became disassociated with the stem.We revised the patient, implanting a new stem spacer, and new poly.
Additional Manufacturer Narrative
Correction: d4 lot, g1 reporting entity, contact.The reported event could be not confirmed.The device was returned for evaluation and functional testing could not confirm the alleged failure mode as the device was found to function as intended.The device inspection revealed the following: visual inspection a visual inspection of the returned stem revealed slight surface scratches and rub marks.Overall, the stem looked to be in excellent condition.Functional inspection: the r&d engineer performed a functional test on the returned stem and a spare poly device.The functional testing revealed that a spare polyethylene component assembly was able to be assembled into the stem that was returned without issue.The spare poly assembled without issue when following the surgical technique.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on analysis of the returned component and provided information, the root cause was attributed to user related issue.The most likely cause of the reported difficulty is due to the user not applying thumb pressure to the polyethylene component prior to impaction.The surgical technique instructs the user to ¿apply hand pressure to begin to engage the locking mechanism.¿ if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The poly became disassocaited with the stem.We revised the patient, implanting a new stem spacer, and new poly.

• Brand Name: PERFORM HUMERAL STEM SZ 2 PLUS
• Common Device Name: SEMI-CONSTRAINED METAL CEMENTED SHOULDER PROSTHESIS
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13169541
• Report Number: 3004983210-2022-00003
• Device Sequence Number: 4464997
• Product Code: PAO
• UDI-Device Identifier: 00846832085422
• UDI-Public: 00846832085422
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 06/23/2026
• Device Model Number: DWX2PS
• Device Catalogue Number: DWX2PS
• Device Lot Number: 7880AW016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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: Required Intervention; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female