MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI HUM HEAD SIZE 5 8X18; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Model Number	7122872
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total shoulder replacement.During surgery, surgeon noted that a tendonous tear of the junction of the supraspinatus and subscapularis tendons existed.Surgeon performed a repair using anchors.Post-op rehabilitation proceeded without incident.However, several months following primary surgery, patient complained of increasing pain, swelling and instability of shoulder joint.Surgeon performed a shoulder arthroscopy, to discover full thickness tears of both of the afore mentioned tendons.Discussed with the patient, where a decision was made to convert the surgery to a reverse shoulder replacement.During surgery today, both humeral and glenoid components were removed, as per the recommended surgical technique.The surgeon has no explanation as to why the patient's rotator cuff tendons deteriorated in such a short period of time, rendering the prosthetic joint unstable, other than his belief that microscopic poly debris may have set up an inflammatory local response that inhibited the tendon tear to heal.All components discarded.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.

• Brand Name: TORNIER SIMPLICITI HUM HEAD SIZE 5 8X18
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• 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: 16124022
• Report Number: 0001649390-2023-00002
• Device Sequence Number: 8418042
• Product Code: PKC
• UDI-Device Identifier: 00846832090457
• UDI-Public: 00846832090457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2023

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 Model Number: 7122872
• Device Catalogue Number: 7122872
• Device Lot Number: 0184AX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female