MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 42MM DIA +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP2423
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corrections: h6 device code, d9 product available to stryker.The reported event was not confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 investigation, the root cause was attributed to a user related issue.The failure was caused by an application of excessive mechanical force during surgery.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient had a dislocation, possibly attributed to night terrors after the initial surgery.The patient underwent a revision surgery to replace the poly insert.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the patient had a dislocation, possibly attributed to night terrors after the initial surgery.The patient underwent a revision surgery to replace the poly insert.

• Brand Name: PERFORM REV INSERT SZ 3/4 42MM DIA +3
• 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: 19140370
• Report Number: 0001649390-2024-00174
• Device Sequence Number: 15305301
• Product Code: PHX
• UDI-Device Identifier: 00846832084524
• UDI-Public: 00846832084524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: DWP2423
• Device Lot Number: 5516AY
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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: Male