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

Catalog Number DWF605B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Swelling/ Edema (4577)

Event Date 03/01/2018

Event Type  Injury  

Event Description

It was reported that a patient presented with an anterior glenohumeral mass.The patient also presented with swelling in the front of the shoulder.Mri revealed a mass.The subject was referred out to an orthopedic oncologist.

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 Description

It was reported that a patient presented with an anterior glenohumeral mass.The patient also presented with swelling in the front of the shoulder.Mri revealed a mass.The subject was referred out to an orthopedic oncologist.

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.

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.

Event Description

It was reported that a patient presented with an anterior glenohumeral mass.The patient also presented with swelling in the front of the shoulder.Mri revealed a mass.The subject was referred out to an orthopedic oncologist.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DG 82MM
• Type of Device: 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: 17396593
• MDR Text Key: 319839675
• Report Number: 3000931034-2023-00222
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWF605B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 08/29/2023
• Supplement Dates FDA Received: 09/21/2023; 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG