MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 46MMX17MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF046
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In the tornier shoulder outcomes study , the patient experienced rotator cuff deficiency and extensive glenoid bone loss in their left shoulder.This condition was assessed as possibly related to both the study device and the surgical procedure.The adverse event outcome is ongoing, and the patient is using thc cream and hydrocodone 10/325 mg for pain relief.Notably, the left shoulder did not have a glenoid implant; instead, isolated reaming/shaping and the use of an allograft (skaffold) were employed.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
In the tornier shoulder outcomes study , the patient experienced rotator cuff deficiency and extensive glenoid bone loss in their left shoulder.This condition was assessed as possibly related to both the study device and the surgical procedure.The adverse event outcome is ongoing, and the patient is using thc cream and hydrocodone 10/325 mg for pain relief.Notably, the left shoulder did not have a glenoid implant; instead, isolated reaming/shaping and the use of an allograft (skaffold) were employed.
Additional Manufacturer Narrative
The reported event was not confirmed since the device was not returned for evaluation (remained implanted) and no other evidences were provided.The opinion of the medical expert was requested on this case despite the limited information provided and stated as following: "this event sounds very much like a rotator cuff tear arthropathy (rtca), which can develop in cases of hemiarthroplasty as well.The abundant swelling of the shoulder joint, necrotic glenoid bone may give the impression of a more serious pathology when not recognized initially.Hence the mri"."we must stick to the fact that this is a hypothesis": issue is most probably "caused by a progressive rotator cuff failure and thereby a strong inflammatory response, which is typical for rcta" (patient's condition) "and that we do not have sufficient information to assess it definitively".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.More detailed information about the complaint event (as imaging information) must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 46MMX17MM
• 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: 17770469
• Report Number: 3000931034-2023-00309
• Device Sequence Number: 7219895
• Product Code: KWS
• UDI-Device Identifier: 03700434022520
• UDI-Public: 03700434022520
• 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,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/08/2020
• Device Catalogue Number: DWF046
• Device Lot Number: AA0437014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 73 KG