MAUDE Adverse Event Report: TORNIER S.A.S. PERFORM HUMERAL STEM SZ 2 PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number	DWX2PS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Dizziness (2194); Urinary Frequency / Polyuria (2275); Confusion/ Disorientation (2553); Bacteremia (4846)
Date of Event	02/16/2023
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.Device disposition is unknown.
Event or Problem Description
The following events were reported by the clinical study site: "(b)(6) 2023 - subject presented to emergency department 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.".
Additional 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.
Event or Problem Description
The following events were reported by the clinical study site: "on (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.On (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.On (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.On (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.On (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 on (b)(6) 2023.Subject discharged home with home health care.To follow up with pcp, appointment scheduled for on (b)(6) 2023.".

• Brand Name: PERFORM HUMERAL STEM SZ 2 PLUS
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, 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: 16629921
• Report Number: 3000931034-2023-00081
• Device Sequence Number: 5324301
• Product Code: PAO
• UDI-Device Identifier: 00846832085422
• UDI-Public: 00846832085422
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: DWX2PS
• Device Catalogue Number: DWX2PS
• Device Lot Number: AE6187002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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 Sex: Female
• Patient Weight: 87 KG