MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI NUCLEUS SIZE 1; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Model Number	DWG401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	05/02/2022
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 was having pain and was diagnosed with rotator cuff deficiency.The patient had a revision surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 was having pain and was diagnosed with rotator cuff deficiency.The patient had a revision surgery.

• Brand Name: TORNIER SIMPLICITI NUCLEUS SIZE 1
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• 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: 14632723
• Report Number: 0001649390-2022-00019
• Device Sequence Number: 5917684
• Product Code: PKC
• UDI-Device Identifier: 00846832091874
• UDI-Public: 00846832091874
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K143552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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 Expiration Date: 11/14/2023
• Device Model Number: DWG401
• Device Catalogue Number: DWG401
• Device Lot Number: CC0118303031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 85 KG