MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN DYNESYS PRODUCT

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Note: the present case was opened on basis of additional information received for (b)(4) (mfr 9613350-2015-00938).Additional information received on june 01, 2016 reports a second patient with similar issue and the case at hand was created.Should additional information become available and an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the patient received a dynesis implant (exact catalogue number unknown) on (b)(6) 2006 and was revised on (b)(6) 2015 due to suspected infection and screw loosening.

Manufacturer Narrative

A technical investigation was not possible to perform, as the devices were not at hand.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis: n/a as no reference number was available.The dhr check could not be performed as the lot number was not available.Event summary: it was reported that the left l4 screw floated up in pus.Suspected infection.Implantation was on (b)(6) 2006 and revision on (b)(6) 2015.No medical data such as x-rays, surgical notes or any other case-relevant documents were received.Root cause determination using rmw: contaminated device would be used due to packaging defective due to inadequate storage conditions by the hospital.Not possible.The infection occurred 9 years after device implantation.Therefore, it is not suspected that the product caused or contributed to any patient infection.Contaminated device would be used due to unintended unwrapping of device packaging.Not possible.The infection occurred 9 years after device implantation.Therefore, it is not suspected that the product caused or contributed to any patient infection.Contaminated device would be used due to explanted implant used for new implantation surgery.Not possible.The infection occurred 9 years after device implantation.Therefore, it is not suspected that the product caused or contributed to any patient infection.Contaminated device would be used due to incorrect reprocessing procedure.Not possible.The infection occurred 9 years after device implantation.Therefore, it is not suspected that the product caused or contributed to any patient infection.Conclusion summary: the product related to the reported event was not available for investigation.In addition, no supplemental information (e.G.X-rays, surgical reports, etc.) was provided.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards.The gamma sterilization specification of the device certifies the suitability of sterilization.The infection occurred 9 years after device implantation.Therefore, it is not suspected that the product caused or contributed to any patient infection.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: UNKNOWN DYNESYS PRODUCT
• Type of Device: UNKNOWN DYNESYS PRODUCT
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5754045
• MDR Text Key: 48299051
• Report Number: 0009613350-2016-01007
• Device Sequence Number: 1
• Product Code: NQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention