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

Model Number	DWF605B
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208); Joint Laxity (4526); Implant Pain (4561)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent shoulder hemi-arthroplasty several years ago.Patient presented to surgeon several months ago with increasing pain & instability in prosthetic shoulder joint.Patient now requires conversion of hemi-arthroplasty to a reverse shoulder arthroplasty, due to shoulder instability secondary to rupture of subscapularis tendon / muscle (according to surgeon).
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation.However, an x-ray and a ct-scan were provided for investigation.The opinion of the medical expert was requested and stated the following: "the x-ray shows a well-place humeral component and pyrocarbon head.There is still some joint space visible.There are no explicit signs of loosening or infection.The initial operative report can maybe provide more information on the quality of the subscapularis tendon and the way taken down and re-attached during this index-surgery in 2018.With no further information i would suggest that this rotator cuff tear most likely is attributable to age-related degeneration of the subscapularis tendon.Regarding the ct-scan, the axial sequence on the left clearly shows the erosion of the posterior part of the glenoid.Although this is a bone-setting showing the soft tissues less detailed, atrophy of the subscapularis muscle belly seems plausible.There are no further details that explain the root cause of the rotator cuff failure, making progressive degeneration the most like cause.The opinion of the r&d expert was requested and stated the following: "there is no immediate post-op x-ray available to confirm the initial prothesis positioning.But the x-ray provide and the ct-scan confirm the bad positioning of the head due to subscapularis tear as expressed by the surgeon.This bad positioning explains the patient pain." more detailed information about the complaint event must be available in order to determine the root cause of the complaint event.But a probable root cause of this event is probably due to the patient condition.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient underwent shoulder hemi-arthroplasty several years ago.Patient presented to surgeon several months ago with increasing pain & instability in prosthetic shoulder joint.Patient now requires conversion of hemi-arthroplasty to a reverse shoulder arthroplasty, due to shoulder instability secondary to rupture of subscapularis tendon / muscle (according to surgeon).

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DEG 82MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15075740
• Report Number: 0001649390-2022-00039
• Device Sequence Number: 17348911
• Product Code: KWS
• UDI-Device Identifier: 03700434021592
• UDI-Public: 03700434021592
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/24/2021
• Device Model Number: DWF605B
• Device Catalogue Number: DWF605B
• Device Lot Number: AA3239017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Male