MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 4 PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number DWX4PS

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that a patient experienced an acromion stress fracture in addition to pain and decreased range of motion.

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.

Event Description

It was reported that a patient experienced an acromion stress fracture in addition to pain and decreased range of motion.

• Brand Name: PERFORM HUMERAL STEM SZ 4 PLUS
• 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15949624
• MDR Text Key: 305150406
• Report Number: 0001649390-2022-00113
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832085507
• UDI-Public: 00846832085507
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWX4PS
• Device Catalogue Number: DWX4PS
• Device Lot Number: CZ1722042003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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