MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWF603A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/03/2020
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.
Event or Problem Description
It was reported that patient had pain and shoulder stiffness and underwent arthroscopic arthrolysis revision.
Event or Problem Description
It was reported that patient had pain and shoulder stiffness and underwent arthroscopic arthrolysis revision.
Additional Manufacturer Narrative
Correction d1, g1 manufacturing site, h5 method code, conclusion code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since data were provided, the opinion of a medical expert was sought and stated as following: -"the initial idea of the diagnosis might have been cuff tear arthropathy, but eventually it was not (primary osteoarthritis) and the treatment was adjusted to that (anatomic instead of reverse)".-"the patient has diabetes mellitus, which increases the risk of a capsulitis (frozen shoulder) after immobilization, trauma or surgery.The fact that physical therapy seemed to have worsened the symptoms is also recognizable.It is often the case that the physical therapist gets the blame for it, but that¿s not correct.The protracted course of the capsulitis (causing pain and stiffness) over two or more years is also noted more often in patients with diabetes.So, in conjunction with the late arthroscopic release and complete resolution of the symptoms, this makes the diagnosis post-surgical capsulitis very likely".-"in conclusion: post-surgical capsulitis of the left shoulder after anatomic shoulder arthroplasty, most likely through the combination of post-operative immobilization, and diabetes mellitus [¿] there is no root cause linked to the device.In this case patient characteristics played an important role".The root cause of the event is most probably due to patient conditions.The diabetes from which the patient suffers is most probably linked to the symptoms reported as per the medical opinion.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
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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 38330 ; EI 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13635133
• Report Number: 3000931034-2022-00129
• Device Sequence Number: 5216120
• Product Code: KWS
• UDI-Device Identifier: 03700434022599
• UDI-Public: 03700434022599
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: 10/16/2024
• Device Model Number: DWF603A
• Device Catalogue Number: DWF603A
• Device Lot Number: AC6942020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG