MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS ASCEND FLEX STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTM

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

Patient Problem Limb Fracture (4518)

Event Date 02/28/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent shoulder surgery.The surgeon intended to use the perform humeral stem but was not able to due to sterilization issues at the hospital.The surgeon elected to change to the ascend flex humeral stem.Therefore the surgeon had to recut the humerus as the ascend flex humeral stem is a different neck shaft angle.During the insertion of the stem, the patient's humerus fractured.No surgical delay was reported.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Medical expert opinion was requested was requested and stated as following: for the device in scope, the patient matched glenoid, the surgeon was satisfied with its use.Since the blueprint planning is ct-based, that means following the contours of the bone, abundant soft tissue out of the periphery of the reamed/prepared area, can still be in place.Unfortunately, the surgeon had an issue of contamination of the perform stem and had to switch to an alternative solution, in this case the surgeon switched to an in-lay (perform stem) to an on-lay (ascend flex) configuration, necessitating more bone removal from the proximal humerus.Since the chosen configuration cannot be compared with the intended perform stem in this patient, it is not possible to assess the tightness of the shoulder with the total construct in place.R&d engineer opinion was requested was requested and stated as following: the hospital did not properly clean all of the perform humeral stem instrumentation, which was discovered when she was preparing to use the humeral compactors (after she had performed the humeral head resection and proximal humeral reaming) for the perform humeral stem.The surgeon elected to change to the ascend flex humeral stem.Therefore she had to recut the humerus as the ascend flex humeral stem is a different neck shaft angle.The patient matched system is compatible and cleared for use with the ascend flex humeral system.The patient matched glenoid allows the surgeon to lateralize the glenoid component more than the perform reversed system, there is potential for the shoulder to be very tight.The difference between an onlay stem (ascend flex) and an inlay stem (perform humeral stem) is well known in terms of the impact on joint tension.With an onlay stem, there is more thickness of the humeral component above the humeral resection which leads to additional join tension.This can be mitigated by adjusting the humeral resection.In this case, the shoulder was tight and the surgeon commented that the patient¿s proximal humeral bone quality was poor.The proximal humerus fractured upon the surgeon¿s initial reduction of the joint.The surgeon¿s comment that the use of the perform humeral stem, as it is an inlay prosthesis, would have been a better selection for this particular case given the patient¿s bone quality is a valid as it would not have caused the joint to be as tight as the ascend flex onlay stem.There have been other successful usages of the patient matched baseplate with the ascend flex stem.This is the only instance of humeral fracture that we are aware of.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the physical size and/or shape of the device was inadequate with regard to the patient's anatomy.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If more information is provided, the case will be reassessed.The device remains implanted in the patient.

• Brand Name: UNKNOWN AEQUALIS ASCEND FLEX STEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15492146
• MDR Text Key: 300638852
• Report Number: 3000931034-2022-00331
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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