MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ502

Device Problem Malposition of Device (2616)

Patient Problem Nerve Damage (1979)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.

Event Description

A revision surgery was performed using the blueprint planning feature: this patient¿s initial surgery was a reverse for fracture not done by dr.(b)(6), long flex was used.Patient seemed to be doing fine but noticed issues.Tests were done an found that the axillary nerve had suffered some damage when the patient was referred to (b)(6).From there the surgeon staged it with a spacer to get a new blueprint so the surgeon could do the revision, baseplate was not placed well so the surgeon wanted to start over.

Manufacturer Narrative

The reported event was not confirmed since the devices were not returned for evaluation and no other evidences were provided.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: ¿please note that many patients have nerve lesions after phf (proximal humeral fracture).These nerve lesions are usually not noted because of the fracture (joint doesn't function properly) and the pain (these fractures are very painful).Therefore, it cannot be tested by physical examination.There are studies however, showing with electromyography (emg) that patients with phf have some neurological lesions in 40-60% of the time.Most of them resolve spontaneously in 3-6 months.Persisting axillary nerve injuries are thought top be in 5-10% of cases.Since we have no emg study of this patient post-trauma it cannot be assessed if this event is related to the implant procedure at all".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected devices must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

Event Description

A revision surgery was performed using the blueprint planning feature: this patient¿s initial surgery was a reverse for fracture , the long flex was used.Patient seemed to be doing fine but noticed issues.Tests were done an found that the axillary nerve had suffered some damage when the patient was referred to the operating surgeon.From there the surgeon staged it with a spacer to get a new blueprint so the surgeon could do the revision, baseplate was not placed well so the surgeon wanted to start over.

• Brand Name: TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 25MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17199811
• MDR Text Key: 317844710
• Report Number: 3000931034-2023-00188
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092123
• UDI-Public: 00846832092123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• 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: 08/31/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWJ502
• Device Lot Number: 3828AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• 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): Required Intervention