MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 1 PLUS LONG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWX1PL

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Joint Dislocation (2374); Subluxation (4525)

Event Date 10/04/2022

Event Type  Injury  

Event Description

It was reported that there was an instability/ subluxation with the implant in the right shoulder with failure of the subscapularis repair.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.

Event Description

It was reported that there was an instability/ subluxation with the implant in the right shoulder with failure of the subscapularis repair.This subject was converted from and anatomic to a reverse as a result of this ae.

Manufacturer Narrative

Please note the correction regarding the g1 and h6 device code: the reported event could be confirmed since x-rays were provided for evaluation that shows superior subluxation of the humerus in relation to the glenoid component.The opinion of the medical expert was requested and stated as following: ¿this case describes rotator cuff failure postoperatively after an anatomic total shoulder arthroplasty.The prosthesis is recognized as the perform stem, humeral head and pe-glenoid.There are several reasons for rotator cuff failure postoperatively.I will list them here for educational purposes as well: 1.Pre-existing rotator cuff pathology: patients with pre-existing rotator cuff tears or tendinopathy may be at higher risk of postoperative cuff failure, as the surgical intervention may cause further damage to the already compromised tissue.2.Failure of surgically released subscapularis tendon to heal postoperatively.3.Surgical technique: the surgical technique used during the procedure can also affect the risk of rotator cuff failure.Improper placement of the implant or excessive tension on the cuff during implantation can lead to cuff failure.4.Implant design: the design of the implant used in the procedure can also play a role in the development of rotator cuff failure.Implants that are too large or too small or those that do not match the patient's anatomy can cause mechanical stress on the cuff and lead to failure.5.Inadequate rehabilitation: proper rehabilitation following surgery is essential for the successful recovery of the rotator cuff.Failure to follow a prescribed rehabilitation program or returning to activities too soon can put additional stress on the cuff and lead to failure.6.Age: older patients may be at higher risk for rotator cuff failure due to a decreased ability of the tissue to heal and regenerate.7.Other medical conditions: patients with diabetes, osteoporosis, or other chronic medical conditions may be at higher risk for rotator cuff failure due to compromised healing capacity of the tissue.The x-ray shows a superior subluxation of the humerus in relation to the glenoid component, indication (also) superior rc insufficiency.If you look carefully, you can see the glenoid component as a negative contrast (dark structure).The x-ray shows correct placement and sizing of the shoulder arthroplasty components.In this case we can think of items 1 and 2 as the most probable explanation for this event.Most likely patient-related, possibly user-related.¿ a device inspection was not possible since the affected device was not returned, and only x-rays were provided for the investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure in order to confirm that it is patient related.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM HUMERAL STEM SZ 1 PLUS LONG
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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 MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16057384
• MDR Text Key: 306234374
• Report Number: 0001649390-2022-00118
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832085385
• UDI-Public: 00846832085385
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DWX1PL
• Device Catalogue Number: DWX1PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 86 KG