MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 42MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ024
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "study: shout subject: (b)(6).Post-operative ae: instability ¿ dislocation subject was at work and caught a large 100 lb crate.Right shoulder dislocated during this event.Revision surgery with removal of 4 prosthetic components on (b)(6) 2024.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were 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.The root cause can be concluded as patient related.The event clearly states the patient caught a very heavy object with the affected shoulder which caused it to dislocate.If the device is returned or if any additional information is provided the investigation will be reassessed.
Event or Problem Description
As reported: "study: shout subject: (b)(6) rev post-operative ae: instability ¿ dislocation subject was at work and caught a large 100 lb crate.Right shoulder dislocated during this event.Revision surgery with removal of 4 prosthetic components on (b)(6) 2024.".

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 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: 20426068
• Report Number: 0001649390-2024-00587
• Device Sequence Number: 7589499
• Product Code: PHX
• UDI-Device Identifier: 00846832090396
• UDI-Public: 00846832090396
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/13/2025
• Device Catalogue Number: DWJ024
• Device Lot Number: CZ1819347
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2020
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 143 KG