MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DG 82MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF605B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Osteolysis (2377)
Date of Event	02/22/2018
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 remains implanted in the patient.
Event or Problem Description
It was reported that a patient is experiencing heterotopic ossification.The patient's shoulder has some lateral cortex deformity and osteolysis along the lateral metaphyseal section of the component with superior humeral migration and severe glenoid erosion.
Event or Problem Description
It was reported that a patient is experiencing heterotopic ossification.The patient's shoulder has some lateral cortex deformity and osteolysis along the lateral metaphyseal section of the component with superior humeral migration and severe glenoid erosion.
Additional Manufacturer Narrative
The reported event was not confirmed since the devices were not returned for evaluation 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 was enrolled in the shout program to undergo the implantation of the tornier flex shoulder system humeral stem (dwf605b) and humeral head (dwf046) as part of a revision surgery for a previous competitor's hemiarthroplasty device.The presence of heterotopic ossification (ae) doesn't necessarily serve as a sole indication for revision.Localized heterotopic ossification is typically associated with the surgical procedure itself.Not with the device.If the ossified soft tissue mass causes clinical concerns such as restricted shoulder movement or pain, it might necessitate a re-operation (rather than a revision) to excise the ossified tissue.Other findings, such as some lateral cortex deformity, osteolysis along the lateral metaphyseal section of the component, superior humeral migration (indicating upward movement of the humerus, consequently causing the device to move upward as well), and significant glenoid erosion, point to the progression of rotator cuff insufficiency and glenoid erosion.These developments can be viewed as a natural progression of the underlying condition, which is the most plausible reason for the need for revision".A device inspection was not possible since the affected devices were not returned.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 about the complaint event as well as the affected devices (images/x-rays, clinical reports, devices ¿) must be available in order to determine clearly the exact root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DG 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: 17366790
• Report Number: 3000931034-2023-00218
• Device Sequence Number: 17982347
• Product Code: KWS
• UDI-Device Identifier: 03700434021592
• UDI-Public: 03700434021592
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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 Model Number: DWF605B
• Device Catalogue Number: DWF605B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/19/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG