MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH C 7.5DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF361C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Memory Loss/Impairment (1958); Loss of consciousness (2418); Implant Pain (4561)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a post operative adverse event that included severe shoulder pain and loss of consciousness that resulted in the fall onto the operated shoulder and loss of memory.
Additional Manufacturer Narrative
The reported event could not be confirmed since the devices were not returned for evaluation (remained in patient) and no other evidences were provided.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: ¿the patient has had a reverse shoulder arthroplasty in 2015.The reason for the sudden pain is not clear".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.In this case, patient conditions may have contributed to this event ("loss of consciousness resulting in fall onto operated shoulder (.)").A review of the device history was not possible because the lot number was not communicated.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 (such as x-rays, surgical reports) is provided, the investigation will be reassessed.The device remains implanted in the patient.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH C 7.5DEG
• 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: 15712542
• Report Number: 3000931034-2022-00356
• Device Sequence Number: 4972477
• Product Code: KWS
• UDI-Device Identifier: 03700434021004
• UDI-Public: 03700434021004
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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 Model Number: DWF361C
• Device Catalogue Number: DWF361C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 49 KG