MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 0MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	07/18/2019
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.H3 other text : device disposition is unknown.
Event or Problem Description
In the case of the shout subject, an acromial fracture was observed postoperatively, even though it was not present before the surgery.The subject reported experiencing pain radiating from the lateral aspect of the arm into the neck and the back of the scapula.A ct scan confirmed the presence of an acromial stress fracture.The issue was ultimately resolved with sequelae.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.The opinion of the medical expert was requested for information on this case (very limited information provided), and stated as following: "an acromial stress fracture is a known adverse effect in rtsa.Also, acromial stress fractures pose a significant risk to female patients undergoing reverse total shoulder arthroplasty.While this procedure can be highly effective in restoring shoulder function, it can place increased stress on the acromion due to altered biomechanics.The unique anatomical and biomechanical differences in female shoulders, such as a smaller acromial undersurface and potentially lower bone density, may make them more susceptible to this type of fracture".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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information (as patient information, surgery information, additional images/x-rays) about the complaint event as well as the affected device must be available in order to clearly determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
In the case of the shout subject, an acromial fracture was observed postoperatively, even though it was not present before the surgery.The subject reported experiencing pain radiating from the lateral aspect of the arm into the neck and the back of the scapula.A ct scan confirmed the presence of an acromial stress fracture.The issue was ultimately resolved with sequelae.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 0TH 0MM OFFSET
• 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: 17760770
• Report Number: 3000931034-2023-00293
• Device Sequence Number: 7210619
• Product Code: KWS
• UDI-Device Identifier: 03700434022155
• UDI-Public: 03700434022155
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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 Catalogue Number: DWF500
• Device Lot Number: UNKNOWN
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 52 KG