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

Model Number DWX2PS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

The poly became disassociated with the stem.We revised the patient, implanting a new stem spacer, and new poly.

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 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
• Type of Device: 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
• MDR Text Key: 283390558
• Report Number: 3004983210-2022-00003
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832085422
• UDI-Public: 00846832085422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female