MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS PYROCARBON HUMERAL HEAD; SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED

Catalog Number UNK_WTM

Device Problem Material Erosion (1214)

Patient Problem Loss of Range of Motion (2032)

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

Event Description

The patient was operated 10 years ago for stabilisation of the shoulder, with the help of a long plate and screws.He has some plexus disorder (nerve disorder) that make that he had no pain nor any sensation.In 2016 he received a tornier flex pyrocarbon humeral head, because of humeral head arthrosis.Then he was not seen during 7 years.Then in (b)(6) the surgeon had a visit and x-rays from the patient : on xrays, the plate seems to have stared to wear the pyc head.(b)(6) informed the surgeon that this situation is known : graphite and pyc powder has been shown to be biocompatible, but nevertheless the wear process will not self stabilize, so functionning of the prosthesis will be progressively degraded, by change of shape of the head.Surgeon insisted on the patient to schedule a revision, but patient refuses : he says despite he has little mobility, he has no pain (probably because his nerve defect!), and since he is a self entrepreneur working a lot, he has no time to be reoperated.So no revision is scheduled, and surgeon will continue to follow the patient as now.

Manufacturer Narrative

Correction results and conclusion codes the reported event could be confirmed, since x-rays were provided.A device inspection was not possible since the affected device was not returned.Since data and x-ray and medical report, the opinion of the medical expert was requested and stated as following: the x-ray from 2016 of the index surgery shows an implanted ascend flex with a pyrocarbon head.The glenoid side shows the result after open reposition and internal fixation (orif) of an (in the meantime healed) intra-articular glenoid fracture.The x-rays of 2023 are concerning.They show that the contact between the metal plate and the pyrocarbon head has led to macroscopic abrasive wear of the pyrocarbon head.Although graphite may be inert in a biological environment, i am concerned about the contact between the metal plate and the humeral head coupler generating metallosis of the joint with the formation of pseudo-tumors and bone resorption.There is marked bone resorption at both the glenoid and humeral side.Left untreated it will further destroy the bone and the surrounding soft tissues progressively over time, burning bridges for future treatment options.The product was used against the clear warning in the documentation.So unfortunately, postoperatively the bone did resorb/remodel causing contact between the plate and the prosthesis.The surgeon took a big risk implanting the prosthesis under these circumstances.Based on investigation, the root cause was attributed to a user related issue.The event was caused because the product was used against the clear warning in the documentation.So unfortunately, postoperatively the bone did resorb/remodel causing contact between the plate and the prosthesis.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 did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The patient was operated 10 years ago for stabilisation of the shoulder, with the help of a long plate and screws.He has some plexus disorder (nerve disorder) that make that he had no pain nor any sensation.In 2016 he received a tornier flex pyrocarbon humeral head, because of humeral head arthrosis.Then he was not seen during 7 years.Then in january the surgeon had a visit and xrays from the patient : on xrays, the plate seems to have stared to wear the pyc head.M.Hassler informed the surgeon that this situation is known : graphite and pyc powder has been shown to be biocompatible, but nevertheless the wear process will not self stabilize, so functionning of the prosthesis will be progressively degraded, by change of shape of the head.Surgeon insisted on the patient to schedule a revision, but patient refuses : he says despite he has little mobility, he has no pain (probably because his nerve defect!), and since he is a self entrepreneur working a lot, he has no time to be reoperated.So no revision is scheduled, and surgeon will continue to follow the patient as now.

• Brand Name: UNKNOWN AEQUALIS PYROCARBON HUMERAL HEAD
• Type of Device: SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM 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: 16800239
• MDR Text Key: 313898582
• Report Number: 3000931034-2023-00117
• Device Sequence Number: 1
• Product Code: QKW
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 06/30/2023
• 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 Age: 55 YR
• Patient Sex: Male