MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 42MM DIA, +6 VE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number	DWS2426
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/25/2022
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.Device disposition is unknown.
Event or Problem Description
It was reported that a patient had a acromion stress fracture.The patient did not experience a decrease in the range but he experienced an increase in pain.
Event or Problem Description
It was reported that a patient had a acromion stress fracture.The patient did not experience a decrease in the range but he experienced an increase in pain.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation.The device remains implanted in the patient.At a two month follow up it was noted via x-rays, ¿a probable stress fracture of the junction of the scapular spine and the acromion.The implant remains well-seated.¿ a device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the labeling and the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.The medical expert¿s opinion received by the study case manager was reviewed: ¿acromial fractures after rtsa are a complication neither uncommon nor negligible.The reported incidence of acromial fractures after rtsa ranges from 0.6% to 15.8%.Nondisplaced fractures, if detected early, can be treated conservatively, as is done in this case: 6 weeks of immobilization with cessation of physical therapy exercises.Wait and see." more information as well as the affected device must be available in order to determine the exact root cause of the alleged event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM REV INSERT SZ 3/4, 42MM DIA, +6 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15950366
• Report Number: 0001649390-2022-00114
• Device Sequence Number: 7334861
• Product Code: PAO
• UDI-Device Identifier: 00846832078134
• UDI-Public: 00846832078134
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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 Expiration Date: 11/18/2025
• Device Model Number: DWS2426
• Device Catalogue Number: DWS2426
• Device Lot Number: AD238903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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 Sex: Male
• Patient Weight: 92 KG