MAUDE Adverse Event Report: TORNIER INC TORNIER FLEX SHOULDER SYS STD HUM CMT STEM 4B 132.5DEG 74MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF704B
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2023
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
Shoulder arthroplasty was performed for right shoulder osteoarthritis on (b)(6) 2023.Revision surgery will be performed on (b)(6) 2023 because implant placement of the humeral stem at the first surgery was not good.There was maybe not product issue but procedural issue because the sales rep reported no product malfunction was confirmed.
Additional Manufacturer Narrative
Please note the corrections to the h6 health impact code: the reported event could be confirmed.The device was not returned ("because no product malfunction was confirmed") but evidences were provided, based on provided x-rays, which matches the alleged failure.Since x-rays were provided, the opinion of a medical expert was sought and stated as following: "this is a procedure-related, surgeon-related adverse event.The improper position of the humeral stem (ascend flex) is most likely related to bone preparation and cementing issues leaving the humeral component in too much varus and standing proud above the intended depth.It is surprising that it was not corrected immediately, as the malposition was noted during the first surgery.The implant assembly looks completely intact, and i see no issue in sizing.All in all, not a device-related adverse event, but a user-related one".Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a procedure-related adverse event (improper position of the humeral stem noted in per-op).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.If more information is provided, the case will be reassessed.
Event or Problem Description
Shoulder arthroplasty was performed for right shoulder osteoarthritis on (b)(6) 2023.Revision surgery will be performed on (b)(6) 2023 because implant placement of the humeral stem at the first surgery was not good.There was maybe not product issue but procedural issue because the sales rep reported no product malfunction was confirmed.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM CMT STEM 4B 132.5DEG 74MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 16743956
• Report Number: 0001649390-2023-00056
• Device Sequence Number: 6446145
• Product Code: KWS
• UDI-Device Identifier: 03700434022629
• UDI-Public: 03700434022629
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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 Expiration Date: 02/04/2025
• Device Model Number: DWF704B
• Device Catalogue Number: DWF704B
• Device Lot Number: CZ4320009024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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: Other
• Patient Sex: Female