MAUDE Adverse Event Report: ZIMMER GMBH STEM MS-30 12, POLISHED; MS-30 FEMORAL STEM

Catalog Number 30.00.49-120

Device Problem Positioning Problem (3009)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 06/18/2015

Event Type  Death  

Event Description

It was reported, that a stem ms-30 12, polished, should be implanted on (b)(6) 2015.During the procedure, the surgeon prepared the femur for an ms30 cemented femoral stem.Surgeon broached to a size 12 broach and trialled a stf offset configuration with the multipolar.The trial broach sat appropriately in the femur.The surgeon introduced cement into the femoral canal.During definitive stem insertion, surgeon was unable to fully seat implant with the implant sitting up by approx 10mm.Decision was made by surgeon to remove ms30 stem and cement from the femoral canal prior to cement setting.After approx 10-15 minutes after the stem and cement were removed, patient went into cardiac arrest and was unable to be resuscitated.

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Manufacturer Narrative

The device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend identified.The compatibility check was performed and showed that the product combination used is approved by zimmer.Review of incoming information: based on the available information it cannot be assessed why a (b)(6) patient went into cardiac arrest and was unable to be resuscitated 10-15 min after the removal of stem and cement.The conclusion can be only hypothetical.It is not known whether the patient was at cardiac risk or even if a connection exists for cementing.If there was a connection for cementing the femur, it would be relevant to know whether the surgeon performed a medullary cavity lavage prior to cementing.In numerous publications it has been advised of the problems of thromboembolic complications.Additionally pathophysiological causes were recognized early in the context of intravasation of thromboembolic particles during prosthesis implantation.Intramedullary pressure measurements showed high pressure peaks that can be seen in a causal relationship.Massive intravasation of bone marrow constituents occur relatively rare, but can cause a fatal cardiovascular impairment in the sense of thromboembolic complications.Peri- and post-operative pulmonary embolism is the most frequent cause of death during the cemented hip-implantation nowadays.At the present state of recorded knowledge, the increase in intermedullary pressure (imd) and the amount of potentially thrombogenic material in the femoral shaft constitute the decisive factors in the pathophysiological mechanism for the formation of bone marrow embolisms during the surgery.The jet lavage (high pulsatile lavage) is thus a technique which provides benefits in both the biomechanical purposes and to avoid embolization.Review of internal documents: correct implantation method of the ms-30 femoral stem is explained in the surgical technique for the cemented ms-30 hip prosthesis sterilization certificate of the ms-30 stem was reviewed.The sterilization certificate confirms that the product was sterilized according to the specifications.Possible causes for the reported event according to dfmea: a) line 12: adverse body reaction (eg.Cancer, allergies etc.) -> due to bioincompatible device due to harmful leachables from implant material" b) line 36: infection -> due to implant contaminated during handling c) line 39: adverse body reaction (eg.Cancer, allergies etc.) -> due to material not biocompatible d) line 60: transmission of infectious agents, infection -> due to reuse of the device which is only intended for single use comparison to investigation results whether it is possible and justification: a) line 12: not possible -> biocompatibility of the material ls validated according to biocompatibility specification b) line 36: possible -> wrong handling of the device is out of zimmer biomet control c) line 39: not possible -> biocompatibility of the materia ls validated according to biocompatibility specification d) line 60: possible -> even though it is suggested not to be re-used, ifu (chapter ""warnings - single use only - do not re-use" " symbol on box label: ""not to be re-used"") neither x-rays, operative notes, nor devices or photos of the implants were received; therefore the condition of the components is unknown.Patient factors that may affect the implantation procedure such as bone quality or relevant medical history are unknown.Anaesthesia protocol and treatment plan is unavailable.Complaint history search based on the complaints recorded since the beginning of documentation showed no similar cases for the products employed in the surgery.Device manufacturing history records of the devices indicate that the released components from the respective batches met all requirements to perform as intended.Sterilization certificates of the devices show that the articles were sterilized according to the specifications.Single-use, sterilized devices manufactured or distributed by (b)(6) are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is not suspected that the products caused or contributed to any patient infection.Based on the device history records, complaint histories of the relevant products, sterilization certificates and health care professional's review on the case there is no indication that the involved zimmer products contributed to the event.Therefore, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: STEM MS-30 12, POLISHED
• Type of Device: MS-30 FEMORAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4894035
• MDR Text Key: 22244493
• Report Number: 9613350-2015-00716
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 30.00.49-120
• Device Lot Number: 2792407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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): Death
• Patient Age: 95 YR