MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS ASCEND FLEX HUMERAL STEM; PROSTHESIS SHOULDER JOINT METAL/POLYMER

Catalog Number UNK_WTM

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

Patient Problems Nerve Damage (1979); Numbness (2415); Swelling/ Edema (4577)

Event Date 03/22/2022

Event Type  Injury  

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by (b)(6) healthsystem, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis ascend flex shoulder system¿, which is associated with the stryker ¿aequalis ascend flex shoulder ¿system.This report includes analysis of the clinical data that was collected on 179 patients, the cases in this study range from 2013-2020.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced numbness, swelling and persistent ulnar nerve symptoms.The report states: (b)(6) with a reverse total shoulder.At one-month post-op visit was noted to have numbness in the forearm and hand.Initially felt to be a possible brachial plexopathy.Subsequent emg demonstrated carpal tunnel and cubital tunnel syndromes.Post-operative swelling the upper extremity following the total shoulder was felt to be related to developing the numbness.When seen at six months postoperative, he had persistent ulnar nerve symptoms but was doing well with the total shoulder.He expired from other causes the following week.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged numbness, swelling and persistent ulnar nerve symptoms could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by northshore university healthsystem, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis ascend flex shoulder system¿, which is associated with the stryker ¿aequalis ascend flex shoulder ¿system.This report includes analysis of the clinical data that was collected on 179 patients, the cases in this study range from (b)(4).During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced numbness, swelling and persistent ulnar nerve symptoms.The report states: ¿85-year-old with a reverse total shoulder.At one-month post-op visit was noted to have numbness in the forearm and hand.Initially felt to be a possible brachial plexopathy.Subsequent emg demonstrated carpal tunnel and cubital tunnel syndromes.Post-operative swelling the upper extremity following the total shoulder was felt to be related to developing the numbness.When seen at six months postoperative, he had persistent ulnar nerve symptoms but was doing well with the total shoulder.He expired from other causes the following week.¿.

Manufacturer Narrative

Correction: h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.

Manufacturer Narrative

Please refer to g2 initial reporter intake source is post market study.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by northshore university health system, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis ascend flex shoulder system¿, which is associated with the stryker ¿aequalis ascend flex shoulder ¿system.This report includes analysis of the clinical data that was collected on 179 patients, the cases in this study range from 2013-2020.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced numbness, swelling and persistent ulnar nerve symptoms.The report states: ¿85-year-old with a reverse total shoulder.At one-month post-op visit was noted to have numbness in the forearm and hand.Initially felt to be a possible brachial plexopathy.Subsequent emg demonstrated carpal tunnel and cubital tunnel syndromes.Post-operative swelling the upper extremity following the total shoulder was felt to be related to developing the numbness.When seen at six months postoperative, he had persistent ulnar nerve symptoms but was doing well with the total shoulder.He expired from other causes the following week.¿.

• Brand Name: UNKNOWN AEQUALIS ASCEND FLEX HUMERAL STEM
• Type of Device: PROSTHESIS SHOULDER JOINT METAL/POLYMER
• 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: 14148031
• MDR Text Key: 291288620
• Report Number: 3000931034-2022-00168
• 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): Y
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2024

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: 03/22/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 03/28/2024; 05/23/2024
• Supplement Dates FDA Received: 03/28/2024; 05/24/2024
• 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
• Patient Age: 85 YR