MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM HEAD HI OFFSET 39MMX14MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF139
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Total shoulder arthroplasty was performed for a patient with osteoarthritis of right shoulder.The tendency of dislocation of the humeral nail was observed on one week post-op.Manual reduction was performed for work around on that day and revision surgery was performed on 2 days later.The doctor commented it was thought that dislocation occurred because the humeral stem was implanted in a state where the anteversion angle of it was wider than expected.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not returned.
Event or Problem Description
Total shoulder arthroplasty was performed for a patient with osteoarthritis of right shoulder.The tendency of dislocation of the humeral nail was observed on one week post-op.Manual reduction was performed for workaround on that day and revision surgery was performed on 2 days later.The doctor commented it was thought that dislocation occurred because the humeral stem was implanted in a state where the anteversion angle of it was wider than expected.
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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD HI OFFSET 39MMX14MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18022260
• Report Number: 3000931034-2023-00376
• Device Sequence Number: 6538563
• Product Code: KWS
• UDI-Device Identifier: 03700434021783
• UDI-Public: 03700434021783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 07/27/2026
• Device Catalogue Number: DWF139
• Device Lot Number: AD7789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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: 74 YR
• Patient Sex: Female