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

Catalog Number DWG401

Device Problem Migration (4003)

Patient Problems Muscle/Tendon Damage (4532); Implant Pain (4561)

Event Date 04/01/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331215008
• Report Number: 0001649390-2023-00369
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00846832091874
• UDI-Public: 00846832091874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWG401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7122869 TORNIER SIMPLICITI HUM HEAD SIZE 4 1X15
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 56 KG