MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 42MM 9TH A 17.5DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF422A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Loss of Range of Motion (2032); Joint Dislocation (2374)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient fell on ice and got a dislocated shoulder.The emergency room was unable to relocate shoulder so the patient stayed overnight and then was taken to the operating room next morning for relocation under anesthesia.The patient remains pseudoparalytic and will be worked up for a revision rsa.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the involved devices were not returned for evaluation and no additional information will be provided.Since the medical reports were provided, the opinion of the medical expert was requested and stated as following: "the previous surgeries and the trauma are enough reason for chronic instability and the need for (re-)revision of the right shoulder".More detailed information about the complaint event as well as the affected device must be available in order to determine the exact 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
It was reported that the patient fell on ice and got a dislocated shoulder.The emergency room was unable to relocate shoulder so the patient stayed overnight and then was taken to the operating room next morning for relocation under anesthesia.The patient remains pseudoparalytic and will be worked up for a revision rsa.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 42MM 9TH A 17.5DEG
• 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): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14206450
• Report Number: 3000931034-2022-00212
• Device Sequence Number: 19929406
• Product Code: KWS
• UDI-Device Identifier: 03700434020328
• UDI-Public: 03700434020328
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2022

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: 06/29/2023
• Device Model Number: DWF422A
• Device Catalogue Number: DWF422A
• Device Lot Number: 8874AT015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 147 KG