MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2, 39MM DIA, +0 VE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number	DWS1390
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient fell on (b)(6) 2023 onto left posterior/lateral shoulder.X-ray (b)(6) 2023 shows no fracture.On (b)(6) 2023 patient heard & felt a tear in the posterior part of shoulder while changing her shirt.Went to er on (b)(6) 2023.X-ray showed mildly comminuted fracture through the acromion without appreciable displacement.No dislocation of device.
Additional Manufacturer Narrative
The reported event was confirmed through the evaluation of a medical expert.The medical opinion of a medical expert was requested to evaluate the risk of this event: the event of a scapular fracture can be confirmed on the x-rays.The event is possibly linked to the study device and most likely to the sustained fall.The x-ray shows indeed no fracture after the fall in (b)(6) 2023, yet one week later an acromion fracture happened.This fracture most likely related to the fall.The study device looks fine in all radiological aspects.It is possible that the rtsa in this patient has made the acromion more susceptible for a (traumatic) fracture.» based on the above investigation and provided information, the root cause was attributed to a patient related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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 fell on (b)(6),2023 onto left posterior/lateral shoulder.X-ray (b)(6) 2023 shows no fracture.On (b)(6) 2023 patient heard & felt a tear in the posterior part of shoulder while changing her shirt.Went to er on (b)(6) 2023.X-ray showed mildly comminuted fracture through the acromion without appreciable displacement.No dislocation of device.

• Brand Name: PERFORM REV INSERT SZ 1/2, 39MM 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: 16981291
• Report Number: 0001649390-2023-00105
• Device Sequence Number: 6163642
• Product Code: PAO
• UDI-Device Identifier: 00846832078028
• UDI-Public: 00846832078028
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• 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: DWS1390
• Device Catalogue Number: DWS1390
• Device Lot Number: CZ5622129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG