MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4B 132.5DEG 78MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF604B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned as it remained implanted.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that patient (b)(6) had a post-operative complication due to infection (intraoperative cultures positive for c acnes).Action taken: medication, "iv antibiotics managed by infectious disease".(b)(6) 2021: "patient now on oral antibiotics".
Additional Manufacturer Narrative
The device will not be returned as it remained implanted.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that patient (b)(6) had a post-operative complication due to infection (intraoperative cultures positive for c acnes).Action taken: medication, "iv antibiotics managed by infectious disease".(b)(6) 2021: "patient now on oral antibiotics".
Event or Problem Description
It was reported that patient (b)(6) had a post-operative complication due to infection (intraoperative cultures positive for c acnes).Action taken : medication, "iv antibiotics managed by infectious disease".On (b)(6) 2021: "patient now on oral antibiotics".
Additional Manufacturer Narrative
Corrections: refer to d2a common device name.Additional devices listed in this report: cat dwf520 flex shoulder system reversed tray dia.40 th 0 ecc 3.5 lot code unknown.Cat dwf422b flex shoulder system rev insert d42 th+9 std angle 12.5/b lot code unknown.Cat dwj502 perform reversed lateralized baseplate +3mm dia 25mm lot code unknown.Cat dwj024 perform reversed lateralized glenosphere +3 dia 42mm lot code unknown.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ a review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4B 132.5DEG 78MM
• 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: 12939547
• Report Number: 3000931034-2021-00351
• Device Sequence Number: 4820142
• Product Code: KWS
• UDI-Device Identifier: 03700386944574
• UDI-Public: 03700386944574
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: DWF604B
• Device Catalogue Number: DWF604B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/28/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male