MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2, 36MM DIA, +0 VE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number	DWS1360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Loss of Range of Motion (2032); Limb Fracture (4518)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned 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.
Event or Problem Description
It was reported that patient (b)(6) developed an acromial fracture.The patient will be undergoing nonoperative treatment and will be immobilized in a sling.Patient will follow up in 6 weeks.
Additional Manufacturer Narrative
Correction - h6 (clinical signs code).
Event or Problem Description
It was reported that patient 01-013 developed an acromial fracture.The patient will be undergoing nonoperative treatment and will be immobilized in a sling.Patient will follow up in 6 weeks.

• Brand Name: PERFORM REV INSERT SZ 1/2, 36MM DIA, +0 VE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16800547
• Report Number: 0001649390-2023-00075
• Device Sequence Number: 19598432
• Product Code: PAO
• UDI-Device Identifier: 00846832077991
• UDI-Public: 00846832077991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: DWS1360
• Device Catalogue Number: DWS1360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/26/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 78 KG