MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3A 127.5DEG 74MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF603A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	07/28/2022
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.Additional devices listed in this report: dwf510 tornier flex shoulder sys rev tray 0th 1.5mm offset.Dwf361b tornier flex shoulder sys rev insert 36mm 6th b 12.5deg.Dwj401 tornier perform reversed stand ard baseplate 25mm.Dwj022 tornier perform reversed later alized glenosphere +3 dia 36mm.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient had post-operative pain which limited their range of motion.Through ct scans it was revealed that the patient had inferior osteophyte.
Additional Manufacturer Narrative
Please note correction in h6 health impact: the reported event could not be confirmed since no other evidences were provided.The device inspection was not possible as the products were not returned for investigation.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: ¿as the surgeon performed an extensive release of soft tissues and the motion interfaces (arthroscopic debridement, capsular release, subacromial decompression, exostosis, removal of posterolateral acromion, and removal of sutures), i do not believe we can blame to inferior osteophyte to be the reason for the limited range of motion.The shoulder was still fine a couple of months before the ae was reported and osteophytes do not develop in such a short time".Moreover, an osteophyte can be defined as a bony outgrowth, that occurred usually adjacent to an area of articular cartilage damage in a joint, mainly affected by osteoarthritis or due to aging, a condition that causes joints to become painful and stiff.In this case, it is very unlikely that the device could have caused the reported event.More information is required to determine an exact root cause.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient had post-operative pain which limited their range of motion.Through ct scans it was revealed that the patient had inferior osteophyte.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3A 127.5DEG 74MM
• 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: 15285679
• Report Number: 3000931034-2022-00279
• Device Sequence Number: 11364414
• Product Code: KWS
• UDI-Device Identifier: 03700434022599
• UDI-Public: 03700434022599
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DWF603A
• Device Catalogue Number: DWF603A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 11/30/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 54 KG