MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 2B 132.5DEG 70MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF602B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.The device remains implanted in the patient.
Event or Problem Description
It was reported that the patient had a periprosthetic fracture of the reversed shoulder prosthesis which required reoperation with a osteosynthesis plate.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but evidences were provided, based on provided x-rays which matches the alleged failure (postoperative periprosthetic fracture).Since x-rays and additional data were provided, the opinion of a medical expert was sought and stated as following: "the vancouver b1 periprosthetic fracture is well visible on the x-ray"."yes, it is very likely that the earlier fracture and fracture surgeries may have weakened the bone and made the patient more vulnerable for this fracture.This fracture type is common in traumatic fractures around a well-fixed prosthesis.I have the impression that a former screw hole of an earlier plate may have weakened the bone, leading to this fracture type due to the patient¿s fall".Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by a traumatic event (patient's fall, failure helped by the patient¿s previous medical events).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 is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient had a periprosthetic fracture of the reversed shoulder prosthesis which required reoperation with a osteosynthesis plate.Update: the fracture occurred following a fall on (b)(6) 2020.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 2B 132.5DEG 70MM
• 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: 15668109
• Report Number: 3000931034-2022-00352
• Device Sequence Number: 12320753
• Product Code: KWS
• UDI-Device Identifier: 03700434020748
• UDI-Public: 03700434020748
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022
• 2 Devices were Involved in the Event: 1 2

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: DWF602B
• Device Catalogue Number: DWF602B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 72 YR
• Patient Sex: Male