MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM REVERSED FULL WEDGE BP 15 DEG DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Dizziness (2194); Urinary Frequency (2275); Confusion/ Disorientation (2553)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.

Event Description

Complication description: bacteremia.(b)(6) 2023 - subject presented to ed with fever and worsened confusion.Reported fever of 102 f on (b)(6) 2023 along with poor oral intake, dizziness and slight increase in urinary frequency.Denied chills, cough, shortness of breath, diarrhea and burning with urination.(b)(6) 2023 ¿ subject reporting to feel better and acknowledges some gaps in memory.Denies any shortness of breath or chest pain.Now on room air.Kidney function improved and labs within normal limits.Urine culture preliminary results growing e.Coli.No episodes of fever since admission.Wbc wnl.Iv ceftriaxone changed to 2 grams daily.(b)(6) 2023 ¿ no acute events overnight.Subject continues to feel better.Denies any shortness of breath or chest pain.Final result for urine culture growing e.Coli.Preliminary blood culture results growing e.Coli.Repeat blood cultures drawn.(b)(6) 2023 ¿ no acute events overnight.Denies any shortness of breath or chest pain.Continues to improve clinically.Continue iv ceftriaxone 2 grams daily.Id consulted and recommended renal ultrasound to rule out abscess or infectious collection of the kidneys.Renal ultrasound completed with overall unremarkable findings.(b)(6) 2023 ¿ continues to feel better.No acute events overnight.Repeat blood culture preliminary results with no growth to date.Per id, subject to transition to oral levofloxacin 750mg daily through (b)(6) 2023.Subject discharged home with home health care.To follow up with pcp, appointment scheduled for (b)(6) 2023.

Event Description

Complication description: bacteremia.(b)(6) 2023 - subject presented to ed with fever and worsened confusion.Reported fever of 102 f on (b)(6) 2023 along with poor oral intake, dizziness and slight increase in urinary frequency.Denied chills, cough, shortness of breath, diarrhea and burning with urination.(b)(6) 2023 ¿ subject reporting to feel better and acknowledges some gaps in memory.Denies any shortness of breath or chest pain.Now on room air.Kidney function improved and labs within normal limits.Urine culture preliminary results growing e.Coli.No episodes of fever since admission.Wbc wnl.Iv ceftriaxone changed to 2 grams daily.(b)(6) 2023 ¿ no acute events overnight.Subject continues to feel better.Denies any shortness of breath or chest pain.Final result for urine culture growing e.Coli.Preliminary blood culture results growing e.Coli.Repeat blood cultures drawn.(b)(6) 2023 ¿ no acute events overnight.Denies any shortness of breath or chest pain.Continues to improve clinically.Continue iv ceftriaxone 2 grams daily.Id consulted and recommended renal ultrasound to rule out abscess or infectious collection of the kidneys.Renal ultrasound completed with overall unremarkable findings.(b)(6) 2023 ¿ continues to feel better.No acute events overnight.Repeat blood culture preliminary results with no growth to date.Per id, subject to transition to oral levofloxacin 750mg daily through (b)(6) 2023.Subject discharged home with home health care.To follow up with pcp, appointment scheduled for (b)(6)2023.

Manufacturer Narrative

The reported event of infection could be confirmed based on the evidence provided by the clinical study.From data provided, it is reported that the patient, ¿presented to ed with fever and worsened confusion¿.Immediately started on ¿iv ceftriaxone 1 gram daily¿ and hospitalized for four days to monitor.By the fourth day, ¿repeat blood culture preliminary results with no growth to date.Per id, subject to transition to oral levofloxacin 750mg daily¿ for the next seven days and follow up with hcp in 2.5 weeks.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.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.Since data were provided, the opinion of a medical expert was sought and stated as following: ¿please note that in this case the ae is a non-specific general surgical ae, namely a urinary tract infection that was successfully treated with antibiotics.It is non-specific for the type of surgery, and moreover has no anatomical relationship with the shoulder procedure.¿ based on the investigation, the root cause was attributed to a patient related complication not related to the implanted device.In case the item and / or substantive information will become available in the future that suggests otherwise; the investigation will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DEG DIA 25MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16677846
• MDR Text Key: 312650082
• Report Number: 3000931034-2023-00084
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092109
• UDI-Public: 00846832092109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DWJ505
• Device Catalogue Number: DWJ505
• Device Lot Number: 6059AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 87 KG