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

Model Number	DWF500
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Bone Shedding Debris (4557)
Date of Event	04/05/2023
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.
Event or Problem Description
It was reported that the rev ii baseplate, screws, and glenosphere were removed because of notching and loosening.
Additional Manufacturer Narrative
Correction - h6 (clinical signs code, device code).The reported event could be confirmed.The devices were not returned but evidences were provided, based on provided x-ray, which matches the alleged failure.The provided x-ray (pre-op x-ray) shows: -the notching of the humeral component on the scapular - the glenoid implant is located too much superiorly on the glenoid surface, -and the radiolucency around the peripheral screws (present around all screws) and the sphere, indicative of loosening of the baseplate.Since x-ray was provided, the opinion of a medical expert was sought and stated as following: "this case describes notching and loosening of the glenoid component.The x-ray confirms the event.It is however not possible to assess whether the humeral implant has moved due to loosening or if it was placed like that initially.Unfortunately, there is insufficient information (early postoperative x-ray of the index surgery, patient demographics) to make a detailed assessment of a possible root cause".More detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause of the complaint event.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the rev ii baseplate, screws, and glenosphere were removed because of notching and loosening.

• 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): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16997513
• Report Number: 3000931034-2023-00164
• Device Sequence Number: 19677272
• Product Code: KWS
• UDI-Device Identifier: 03700434022155
• UDI-Public: 03700434022155
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: DWF500
• 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): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male