MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	DIAMETER 36MM THICKNESS 6
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Thrown away at facility.
Event or Problem Description
Patient was revised on (b)(6) 2021 due to instability post reverse total shoulder replacement (tornier threaded post baseplate, screws, glenosphere, tray and insert removed by the surgeon in durango co).Tornier flex ptc 6b long stem was reported well fixed by the surgeon, so retained in patient.The patient was compliant to mobilization instructions of the surgeon but not the long term weight restrictions.The surgeon did not want to provide the ct scans.The patient was pulling hoses 9 months post op and felt a "pop" that was presumably a dislocation he states, multiple self reported dislocations, none documented until late winter early of 2021.The surgeon wants to make sure it¿s clearly understood that he has no complaint against our products, just reporting as asked of a revision total shoulder.Reversed insert were implanted.
Additional Manufacturer Narrative
Corrections: please refer to b1 adverse event/product problem, d4 expiration date, h4 manufacturing date and h6 device code.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 as the device was discarded during the surgery.The only data that was reported for this event was the following: the patient was an "active individual, rancher", was "non-compliant with weight restrictions long term", whereas the instructions for use says that: "7.Warnings and cautions: (.) the following situations threaten the success of the shoulder replacement implant: (.) - inability of the patient to follow the surgeon's recommendations and the physical therapy program (.) postoperatively: the surgeon must inform patients: (.) - about the fact that their weight and level of activity can affect the life span of the prosthesis (.)¿.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient was revised on (b)(6) 2021 due to instability post reverse total shoulder replacement (tornier threaded post baseplate, screws, glenosphere, tray and insert removed by the surgeon in durango co).Tornier flex ptc 6b long stem was reported well fixed by the surgeon, so retained in patient.The patient was compliant to mobilization instructions of the surgeon but not the long term weight restrictions.The surgeon did not want to provide the ct scans.The patient was pulling hoses 9 months post op and felt a "pop" that was presumably a dislocation he states, multiple self reported dislocations, none documented until late winter early of 2021.The surgeon wants to make sure it¿s clearly understood that he has no complaint against our products, just reporting as asked of a revision total shoulder.Reversed insert were implanted.

• Brand Name: FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 11866396
• Report Number: 3000931034-2021-00251
• Device Sequence Number: 19925259
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/07/2024
• Device Model Number: DIAMETER 36MM THICKNESS 6
• Device Catalogue Number: DWF361B
• Device Lot Number: AC6802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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: 69 YR
• Patient Sex: Male