MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PRESS FIT SHORT POST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "revision of reverse shoulder which was implanted on (b)(6) 2024, patient had nerve problems, surgeon suspected the glenoid was too lateralized with the wedge implant so wanted to revise to a standard base plate- all implants from the previous case except the ascend humeral stem were replaced with new implants".
Event or Problem Description
As reported: "revision of reverse shoulder which was implanted on (b)(6) 2024, patient had nerve problems, surgeon suspected the glenoid was too lateralized with the wedge implant so wanted to revise to a standard base plate- all implants from the previous case except the ascend humeral stem were replaced with new implants".
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 device inspection was not possible since the affected device 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED PRESS FIT SHORT POST
• 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: 20208951
• Report Number: 0001649390-2024-00535
• Device Sequence Number: 7450592
• Product Code: PHX
• UDI-Device Identifier: 00846832091614
• UDI-Public: (01)00846832091614(11)231012(17)281012(21)9658AZ026
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183696
• 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): 11/14/2024

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: DWJ001
• Device Lot Number: 9658AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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: 55 YR
• Patient Sex: Female