The patient is pursuing a product liability claim.It was reported that the patient was implanted anatomical shoulder reverse, screw system, 4.5-42 on the left side on (b)(6) 2012 and then experienced pain.Patient passed away due to infection and pneumonia which were after effects of previous surgery with plates and screws.
|
Trend analysis: no trend considering the following event is identified: pain or infection.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it is reported that the patient had an as inverse/reverse system implanted on (b)(6) 2012.Before implantation patient had history of failed plate and screw fixation with infection.It is reported that the as inverse/reverse system was implanted once infection was cleared.After implantation the patient experienced pain.Early (b)(6) 2017, patient was aggravated by a cluster of boils under his arm.End of january 2017, patient was given an antibiotic for the infection.The pain increased.The patient died from an untreatable infection which had gone into his lungs after he was given different intravenous antibiotics, which did not work.The infection wasn't cleared up and patient passed on may 19, 2017 due to infection and pneumonia.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Additional information was requested and is currently not available.No product was returned to zimmer biomet for in-depth analysis.Review of product documentation - trabecular metal¿ reverse shoulder system surgical technique showed that the product combination was approved by zimmer biomet.The ifu states that ¿early or late infections¿ are ¿possible consequences of an implant¿ and that the product packaging must be examined for possible damage.Root cause analysis: root cause determination related to infection using dfmea: infection due to failure of sterilization procedure due to design => not possible: the sterilization specification and irradiation certificates of the affected lots have been reviewed and found to be according to specification.Infection due to failure of sterilization procedure due to supplier process => not possible: the sterilization specification and irradiation certificates of the affected lots have been reviewed and found to be according to specification.Infection due to proposed resterilization procedures do not provide sterility => possible: it is unknown if the devices were re-used or re-sterilized before implantation.Thus, it cannot be excluded.Infection due to wrong resterilization procedure for sterile delivered parts => possible: it is unknown if the devices were re-used or re-sterilized before implantation.Thus, it cannot be excluded.Infection due to unsterile implant due to failure of (re-)processing procedure in hospital => possible: it is unknown if the devices were re-used or re-sterilized before implantation.Thus, it cannot be excluded.Transmission of infectious agents, infection due to reuse of the device which is only intended for single use => possible: it is unknown if the devices were re-used or re-sterilized before implantation.Thus, it cannot be excluded.Root cause determination related to pain using dfmea: insufficient primary stability of glenoid baseplate leading to loosening, pain, loss of function due to fixation of screws within bone is insufficient for intended use due to design => not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Soft tissue and nerve damage, loss of joint function, pain due to surgeon uses too long screws into bone => possible: no details about the implantation procedure are available as well as no x-rays which shows the in-vivo situation were provided.Thus, it cannot be excluded.Insufficient primary stability of glenoid baseplate leading to loosening, pain, loss of function due to surgeon uses too short screws into bone => possible: no details about the implantation procedure are available as well as no x-rays which shows the in-vivo situation were provided.Thus, it cannot be excluded.Disassociation, loss of function, pain due to locking strength of screw cap to baseplate, locking the screw position, is insufficient => possible: no details about the implantation procedure are available as well as no x-rays which shows the in-vivo situation were provided.Thus, it cannot be excluded.Conclusion summary: the sterilization specification and irradiation certificates of the affected lots have been reviewed and found to be according to specification.No previous trends have been observed on infection for the product reference numbers as well as for the product lot numbers affected in the complaint.Therefore, it is highly unlikely that a disadvantageous product or packaging design favored or contributed to the infection.Additionally, before implantation of the screws, the patient had history of failed plate and screw fixation with infection.It is reported that the as inverse/reverse system was implanted once infection was cleared (4 weeks of antibiotic fusions).Improper transport, storage and handling of the component could have compromised the sterilization of the products.However, transport, storage and handling of the components is outside of zimmer biomet control.The ifu for endoprosthesis states that ¿early or late infections¿ are ¿possible consequences of an implant¿ and that the product packaging must be examined for possible damage.Potentially something with storage and/or handling of the components outside of zimmer biomet control could have contributed to the reported patient pain and infection or some traces of the previous infection were not cleared from patient body before implantation of the new components.Based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).
|