MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ014
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this case, a revision of stryker implants was performed, involving the revision of both the glenoid sphere and humeral insert.The original x-ray, known as the fluoro, was utilized.Two weeks post-operation, there was a revision to 42 centered, followed by a dislocation of 42 centered, leading to a revised sphere to 42 eccentric and 10-degree poly.The surgeries were planned with blueprint.Despite the patient's history of schizophrenia and chronic anterior dislocation, necessitating multiple revisions, there were no reported issues with the implants themselves.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
In this case, a revision of stryker implants was performed, involving the revision of both the glenoid sphere and humeral insert.The original x-ray, known as the fluoro, was utilized.Two weeks post-operation, there was a revision to 42 centered, followed by a dislocation of 42 centered, leading to a revised sphere to 42 eccentric and 10-degree poly.The surgeries were planned with blueprint.Despite the patient's history of schizophrenia and chronic anterior dislocation, necessitating multiple revisions, there were no reported issues with the implants themselves.
Additional Manufacturer Narrative
The reported event was confirmed, based on the data provided by user/third party.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.However, on the available x-rays medical opinion was sought from an experienced independent medical expert as below, ¿i agree that the dislocations are unmistakably present on the x-rays of the patient¿s shoulder arthroplasty.¿ based on investigation, the root cause was attributed to a patient related issue, as the patient was schizophrenic and was chronic anterior dislocator.Psychiatric disorders are associated with increased medical and surgical complication rates.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18696385
• Report Number: 0001649390-2024-00049
• Device Sequence Number: 15559550
• Product Code: PHX
• UDI-Device Identifier: 00846832090358
• UDI-Public: 00846832090358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: DWJ014
• Device Lot Number: UNKNOWN
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown