MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5C 137.5DEG 82MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF605C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained work related shoulder injury.The patient underwent surgery to repair the rotator cuff tendon tear.There were ongoing complaints of pain and poor function which led to the patient undergoing a shoulder hemi-arthroplasty.The pain and poor range of movement continued.The patient went to another surgeon for further rotator cuff pathology diagnosis.The surgeon that the patient requires conversion of hemi-arthroplasty to reverse shoulder arthroplasty (rsa).The stem and head implants were removed without difficulty.The stem was fixed.A competitor rsa prosthesis implanted.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Kept by surgeon.
Event or Problem Description
It was reported that a patient sustained work related shoulder injury.The patient underwent surgery to repair the rotator cuff tendon tear.There were ongoing complaints of pain and poor function which led to the patient undergoing a shoulder hemi-arthroplasty.The pain and poor range of movement continued.The patient went to another surgeon for further rotator cuff pathology diagnosis.The surgeon that the patient requires conversion of hemi-arthroplasty to reverse shoulder arthroplasty (rsa).The stem and head implants were removed without difficulty.The stem was fixed.A competitor rsa prosthesis implanted.
Additional Manufacturer Narrative
Please note corrections in: b2.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.But based on the event description which mentions that " further rotator cuff pathology diagnosed" and based on the ifu which mentions that "the population targeted with the anatomic configuration is restricted to patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.", the probable root cause of this event is probably due to the patient condition.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.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5C 137.5DEG 82MM
• 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: 15265158
• Report Number: 3000931034-2022-00273
• Device Sequence Number: 5881104
• Product Code: KWS
• UDI-Device Identifier: 03700434021479
• UDI-Public: 03700434021479
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 07/31/2025
• Device Model Number: DWF605C
• Device Catalogue Number: DWF605C
• Device Lot Number: 7561AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/14/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male