MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF364B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
During the consultation for the clinical reassessment of a painful right shoulder, about 4 and a half months from the implantation of a reversed total shoulder prosthesis.The current evolution is more related to a low noise evolution infection than a pain syndrome, as initially suspected.The control of the scar of the day is indeed inflammatory, with a swelling suggesting possible fistulization of the skin infection.Primary surgery was conducted, 5 months later infection was detected.6 months after primary surgery the patient underwent a revision with implant removal and antibiotics.One year post-op the event resolved without sequelae.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since data were provided, the opinion of a medical expert was sought and stated as following: "the images and medical information were reviewed and there are no medical risk factors for this patient for this event (other than being a male patient which increases the risk of a low-grade infection after shoulder arthroplasty a little bit).The x-rays show a correct implantation of the (later explanted) first implants and a correct implantation of humeral tornier flex shoulder/glenoid reversed ii during the one-stage revision surgery in july 2019".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 well as the affected device must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
During the consultation for the clinical reassessment of a painful right shoulder, about 4 and a half months from the implantation of a reversed total shoulder prosthesis.The current evolution is more related to a low noise evolution infection than a pain syndrome, as initially suspected.The control of the scar of the day is indeed inflammatory, with a swelling suggesting possible fistulization of the skin infection.Primary surgery was conducted, 5 months later infection was detected.6 months after primary surgery the patient underwent a revision with implant removal and antibiotics.One year post-op the event resolved without sequelae.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DEG
• 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: 16600259
• Report Number: 3000931034-2023-00072
• Device Sequence Number: 15285054
• Product Code: KWS
• UDI-Device Identifier: 03700434022612
• UDI-Public: 03700434022612
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 12/05/2023
• Device Model Number: DWF364B
• Device Catalogue Number: DWF364B
• Device Lot Number: AC2122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: Male
• Patient Weight: 82 KG