MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 43MMX16MM; SHOULDER JOINT METAL PROSTHESIS

Model Number	DWF043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery: patient underwent i&d (incision and drainage) and implant removal.Subject id: (b)(6).
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery: patient underwent i&d (incision and drainage) and implant removal.Subject id: (b)(6).
Additional Manufacturer Narrative
The reported event (infection) could be confirmed.The device was not returned but evidences were provided based on the reported data in the clinical study.Since data and x-rays were provided, the opinion of the medical expert was requested and stated as following: since there¿s no date on it is difficult to comment on it.Nevertheless the amount of humeral bone loss is significant, so is the space between the one and the lateral aspect of the proximal humerus.That is suspect for (septic) loosening.The swelling, positive culture and earlier implant loosening as reported on the ct-scan are in line with periprosthetic joint infection.In retrospect, the preoperative images show bone loss that may be attributed to infection.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 43MMX16MM
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• 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: 13342731
• Report Number: 3000931034-2022-00010
• Device Sequence Number: 4164539
• Product Code: KWS
• UDI-Device Identifier: 03700434021974
• UDI-Public: 03700434021974
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: DWF043
• Device Catalogue Number: DWF043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 06/02/2022
• 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; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 95 KG