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

Catalog Number	DWG401
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Implant Pain (4561)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a rotator cuff tear (significant / not present pre-op)- patient has been experiencing pain consistent with rotator cuff pathology.X-rays show superior humeral mitigation also consistent with rotator cuff pathology.
Additional Manufacturer Narrative
Additional device used.(b)(6), humeral head.Based on the available information the device remains implanted therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

• 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: 18383618
• Report Number: 0001649390-2023-00369
• Device Sequence Number: 6168309
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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 Catalogue Number: DWG401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 12/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7122869 TORNIER SIMPLICITI HUM HEAD SIZE 4 1X15
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 56 KG