MAUDE Adverse Event Report: TORNIER INC TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DEG 82MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF605B
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cyst(s) (1800); Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient experienced shoulder instability and a small cyst on the shoulder in (b)(6) 2022.The patient presented for ultrasound/biopsy on (b)(6) 2022.On (b)(6) 2022 post op infection was confirmed.The patient underwent a revision procedure to explant the system and replace it with a spacer.
Additional Manufacturer Narrative
Correction - h6 (device code, clinical signs code, health impact code) the reported event could be confirmed.The device was not returned but evidences were provided based on the reported data in the clinical study.From data provided, it is reported that the patient, a male, "had 6/6 positive intraoperative cultures for c acnes.He has been treated (.) with infectious disease and is currently on iv ceftriaxone".Since data were provided, the opinion of a medical expert was sought and stated as following: "the adverse event of infection is not device related.It is a well-know infection type especially in males with a low-virulent skin bacteria, c.Acnes.It is known that this kind of surgical site infection can be dormant for a longer time before becoming symptomatic (several years after index) surgery.The slow build up of fluid in the joint stretches the soft tissues progressively and may lead to joint instability and the formation of a cysts, that may eventually become a fistula if the infection is left untreated.Other than mentioned above there were no other risk factors for infection".Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by skin bacteria (c.Acnes disease).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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient experienced shoulder instability and a small cyst on the shoulder in (b)(6) 2022.The patient presented for ultrasound/biopsy on (b)(6) 2022.On (b)(6) 2022 post op infection was confirmed.The patient underwent a revision procedure to explant the system and replace it with a spacer.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DEG 82MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16210601
• Report Number: 0001649390-2023-00013
• Device Sequence Number: 17256760
• Product Code: KWS
• UDI-Device Identifier: 03700434021592
• UDI-Public: 03700434021592
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Expiration Date: 03/11/2026
• Device Model Number: DWF605B
• Device Catalogue Number: DWF605B
• Device Lot Number: CZ9321035016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 91 KG