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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 03/27/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 315735478
• Report Number: 0001649390-2023-00105
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832078028
• UDI-Public: 00846832078028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 73 KG