MAUDE Adverse Event Report: STRYKER GMBH X3 HUMERAL INSERT - 36MM X 4MM STANDARD; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5571-S-3604

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

Patient Problems Rash (2033); Discomfort (2330)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device remains implanted.

Event Description

As a result of a shoulder injury in (b)(6) 2015, patient underwent a reverse total shoulder arthroplasty using a stryker reunion rsa.The recovery went well, and the patient had an acceptable rom despite some ho on the top of the humerus.At the end of 2016 patient started to experience periods of discomfort.Event 2 of 3.As reported by the patient: since that time, the cyst has not returned; however, level of discomfort has increased, and my rom has gradually decreased.The rash has persisted for the last year and appears to be dynamic ¿ it fades slightly when i am less active (overnight) and intensifies when i am active.The rash appears as a flow of red lines emanating from the site of the cyst.In (b)(6) 2007, i made an appointment with an allergist who performed a standard patch test.It showed that i had an allergy to nickel, but not to titanium, zirconium, cobalt and chromium.I understand that the stryker unit consists of three different metals: three parts made of cobalt/chromium alloy, one part made of titanium/aluminum/vanadium alloy, and one part made of pure titanium.

Manufacturer Narrative

The reported event that a reunion rsa system which was implanted in october 2015 was alleged of having caused an allergic reaction to the patient starting the end of 2016 was taken into account and thoroughly investigated.As stated in the event detail, the three different alloys that are used to produce the reunion rsa system component's are either the cobalt/chromium alloy, or titanium/aluminum/vanadium alloy, or pure titanium.All these different metals' biocomptibility has been extensively tested, and has been proven.The material certificates of the lot numbers used in the different parts reported were certified to be conform to the requirement.As a reminder, the user is responsible of performing the different tests to ensure the compatibility of the implant with the patient's biological needs.As the ifu states: ".[.] precautions ¿ ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.For your information, avail yourself of the training courses and publications offered.[.] " furthermore, it is important to note that allergic reactions in the implant's vicinity is cited as one of the adverse effects that the patient should be informed about.Indeed, the ifu clearly indicates that: " adverse effects [.] ¿ metal sensitivity reactions have been reported following joint replacement.¿ adverse effects may necessitate reoperation, arthrodesis of the involved joint and/or amputation of the limb.¿ wear debris, metal ions and corrosion of metal implants.Generation of wear debris, metal ions and corrosion occurs whenever two surfaces are in contact, and at least one surface is metal.There have been reports in the literature of cases of adverse local tissue reactions associated with wear and/or corrosion at modular junctions formed by modular heads (stem/head interface).Local joint chemistry and/or other patient-specific conditions such as diabetes or infection may affect the potential for in vivo corrosion and its possible clinical consequences.¿ modular junctions release metal debris, metal ions and undergo corrosion (via fretting, galvanic, crevice and other processes) which in some cases may affect the forces acting on the modular junction, the tissues surrounding the implant and duration of service life.There have been reports of patients developing adverse local tissue reactions (including, but not limited to, tissue necrosis, pseudotumors, cysts and fluid accumulations, metallosis and aseptic lymphocyte dominated vasculitis associated lesions), elevated metal ion levels in the blood and/or urine and hypersensitivity/allergic reactions associated with corrosion and / or wear-related debris in the implant vicinity.Affected patients may present with symptoms similar to those associated with infection, including pain (most likely during weight-bearing) and swelling at the local joint site.These reactions should be carefully monitored and may result in early revision surgery.[.]" in addition to : " information for patients ¿ the surgeon must warn the patient of surgical risks and all of the possible adverse effects detailed in the ¿adverse effects¿ section above.The patient should be informed of the limitations of biomaterials and how they will react in the body.It is understood that metal components can wear and/or corrode when in contact with hard surfaces.While the body¿s reaction to such biomaterials is different for every individual, there exists potential for local and systemic effects.[.]" 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As a result of a shoulder injury in october 2015, patient underwent a reverse total shoulder arthroplasty using a stryker reunion rsa.The recovery went well, and the patient had an acceptable rom despite some ho on the top of the humerus.At the end of 2016 patient started to experience periods of discomfort.Event 2 of 3- as reported by the patient: since that time, the cyst has not returned; however, level of discomfort has increased, and my rom has gradually decreased.The rash has persisted for the last year and appears to be dynamic ¿ it fades slightly when i am less active (overnight) and intensifies when i am active.The rash appears as a flow of red lines emanating from the site of the cyst.In august 2007, i made an appointment with an allergist who performed a standard patch test.It showed that i had an allergy to nickel, but not to titanium, zirconium, cobalt and chromium.I understand that the stryker unit consists of three different metals: three parts made of cobalt/chromium alloy, one part made of titanium/aluminum/vanadium alloy, and one part made of pure titanium.

• Brand Name: X3 HUMERAL INSERT - 36MM X 4MM STANDARD
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7577735
• MDR Text Key: 110379289
• Report Number: 0008031020-2018-00449
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098457
• UDI-Public: 07613327098457
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 5571-S-3604
• Device Lot Number: 2T5RJ1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 82