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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bacterial Infection (1735); Sepsis (2067); Inadequate Osseointegration (2646)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a descaling and acute sepsis of the patient's right shoulder.
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 in a supplemental report.Device is implanted in the patient.
Event or Problem Description
It was reported that there was a descaling and acute sepsis of the patient's right shoulder.Late infection of the right pte with sensitive methicillin s aureus.Pte removal and spacer placement on (b)(6) 2021.Seen in emergency for red placard on the scar.: resumption of the delto-pectoral approach.Difficult passage in the groove which is shielded.Opening of the joint and release of a large quantity of frank purulent liquid which is sucked up.Progressive exposure of the prosthesis.The subscapularis is still in place.A high partial tenotomy of the subscapularis is performed, allowing the prosthesis to be dislocated.The baseplate is easily removed with the polyethylene.Exposure of the glenoid reveals complete mobility of the implant.There is therefore a septic loosening.The entire prosthesis is removed from the glenoid side.Curettage of the bone surfaces and of the screw holes and the central post.At this stage, a total explantation is decided.The humerus is therefore referred to and the humeral stem is removed relatively easily.A complete joint synovectomy, detachment, and pulsed lavage with saline mixed with betadine were then performed.Several fluid and tissue samples were taken.: iterative pulsed washing.Metaphyseal preparation with the aid of the ancillary for an inspyre prosthesis (tornier/wright) pyrocarbon diameter 42.Reintegration.Closure of the subscapular by separate ethibond 5 stitches.Good articular stability.Iterative joint cleaning.Plane by plane closure on a redon drain.Staples on the skin.Dressing.Post-operative follow-up: arm in a simple sling for one month.No re-education other than fingers, wrist and elbow.Probabilistic antibiotic therapy to be adapted secondarily to the results of the samples.
Additional Manufacturer Narrative
Please note corrections in the h6 device codes, clinical signs code, results, and conclusion code: the reported event could be confirmed, since the medical records confirm the infection and the loosening.The medical records were available and provided to the medical expertise for his opinion: "i believe the loosening is a result of the infection, and the mechanical stress applied to the joint during opening of the can most likely provoked the already loosening glenoid construction, causing the moment of acute pain.Infection will cause an inflammatory response of the whole joint, including the device-bone interfaces (the surgeon reports that also the humeral component was easily removed from the bone).The infection was caused by a typical skin bacterium, infecting the whole joint, including the graft.The origin of the infection is not due to the graft, the autograft itself is sterile when taken from the patient¿s own humerus." the root cause of this event is due to an infection caused by a typical skin bacterium.This infection then led to the loosening of the device.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 15280108
• Report Number: 3000931034-2022-00277
• Device Sequence Number: 7308000
• Product Code: KWS
• UDI-Device Identifier: 03700434022599
• UDI-Public: 03700434022599
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/27/2022
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG