MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-48; INVERSE/REVERSE SCREWS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Pain (1994); Pneumonia (2011)

Event Date 05/19/2017

Event Type  Death  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records were reviewed and found to be conforming a cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Additional information has been requested and is currently not available.(b)(4).

Event Description

It was reported that the patient was implanted anatomical shoulder reverse, screw system, 4.5-48 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.

Manufacturer Narrative

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 (b)(6) 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 (b)(6) 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).

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-48
• Type of Device: INVERSE/REVERSE SCREWS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6720598
• MDR Text Key: 80244475
• Report Number: 0009613350-2017-00975
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.048
• Device Lot Number: 2660086
• Other Device ID Number: 00889024483064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 70 YR
• Patient Weight: 75