MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3C 137.5DEG 74MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF603C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a post-operative complication.Patient underwent component removal."excentration of the humeral prosthesis with postero superior glenoid wear which lead to shoulder pains and motion limitations.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device disposition is unknown.
Additional Manufacturer Narrative
The reported event (implant - migration) could be confirmed.The device was not returned but evidences were provided based on the reported data (x-ray and medical report).A device inspection was not possible since the affected device was not returned for investigation.Since data and x-ray and medical report, the opinion of the medical expert was requested and stated as following: this case describes the revision of a flex shoulder system pyrocarbon humeral head because of pain and limitation of motion.Please note that the revision has taken place approximately 7 years after the index-surgery.The x-rays show status after rotator cuff surgery (suture anchors and little suture plate in place) and the flex shoulder system with the pyrocarbon humeral head.The x-rays show the eccentric glenoid wear posterosuperior.The surgeon describes the rupture of the rotator cuff.Pain is a difficult matter however and due to the inflammatory response of many structures in the joint, it is difficult to appoint the exact structure that is causing the most pain.In this case, the root cause is rotator cuff deficiency and glenoid wear, and most like acromial abutment and overstuffing may play a role as well.The residual risks of progressive rotator cuff failure and of the wear of the native glenoid are disclosed in the risk management file.Based on investigation, the root cause was attributed to a patient condition related issue.The failure was caused by rotator cuff deficiency and glenoid wear.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
It was reported that the patient had a post-operative complication.Patient underwent component removal."excentration of the humeral prosthesis with postero superior glenoid wear which lead to shoulder pains and motion limitations.".

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3C 137.5DEG 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): 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: 15620288
• Report Number: 3000931034-2022-00349
• Device Sequence Number: 6546652
• Product Code: KWS
• UDI-Device Identifier: 03700434019728
• UDI-Public: 03700434019728
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 09/03/2019
• Device Model Number: DWF603C
• Device Catalogue Number: DWF603C
• Device Lot Number: 6446AO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 74 KG