MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 36MM DIA +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
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
A patient underwent a right reverse shoulder arthroplasty (rsa).A postoperative x-ray revealed that the polyethylene insert was not properly seated in the humeral stem.The patient underwent a revision rsa the following day, where a new reverse insert was implanted.Additional feedback from a sales representative confirmed that during a second surgery, it was observed that the polyethylene insert was not fully seated in the humeral stem.The patient was returned to the operating room for a revision, and it was confirmed that the insert was not fully inserted.The surgeon requested an evaluation of the insert for defects.In a phone call with a representative, it was noted that there was no surgical delay, the patient was kept overnight.
Event or Problem Description
A patient underwent a right reverse shoulder arthroplasty (rsa).A postoperative x-ray revealed that the polyethylene insert was not properly seated in the humeral stem.The patient underwent a revision rsa the following day, where a new reverse insert was implanted.Additional feedback from a sales representative confirmed that during a second surgery, it was observed that the polyethylene insert was not fully seated in the humeral stem.The patient was returned to the operating room for a revision, and it was confirmed that the insert was not fully inserted.The surgeon requested an evaluation of the insert for defects.In a phone call with a representative, it was noted that there was no surgical delay, the patient was kept overnight.
Additional Manufacturer Narrative
Correction: please note the addition of the 510k number.The reported event was not confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following the returned insert shows normal signs of usage confirming it is being used on the patient.Functional test of the returned device is performed with the testing fixture -167-504 which reveals that the insert seated appropriately after using hand pressure and three impactions.It would not pull out from the fixture hence it can be concluded that the issue noted in the event description is not confirmed.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 the investigation insert is well fixed to the testing fixtures hence it can be concluded that the reported event is not confirmed.If any further information is provided the complaint report will be updated.

• Brand Name: PERFORM REV INSERT SZ 1/2 36MM DIA +0
• 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: 19561544
• Report Number: 0001649390-2024-00270
• Device Sequence Number: 7550106
• Product Code: PHX
• UDI-Device Identifier: 00846832084395
• UDI-Public: 00846832084395
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: DWP1360
• Device Lot Number: 5605AZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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 Age: 62 YR
• Patient Sex: Female