MAUDE Adverse Event Report: ZIMMER GMBH DUAL MODULAR STEM; UNKNOWN

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were received, the device history records could not be reviewed.  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).

Event Description

A patient is pursuing a product liability claim.It was reported that a patient had a dual medular stem metal on metal hip implanted on (b)(6) 2012 and was revised on (b)(6) 2016 due to pain, metallosis, heterotropic ossification with corrosion, elevated metal ions and wear.

Manufacturer Narrative

As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh (b)(4) legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the device was not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis was not performed as item number was not available.Device history records (dhr): the dhr check could not be performed as the lot number was not available.As no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device data information was sent.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: patient had received unknown zimmer modular stem metal on metal hip replacement on (b)(6) 2012 and revised on (b)(6) 2016 due to pain, metallosis, heterotropic ossification with corrosion, elevated metal ions and wear after 4 years in-vivo time.No product was returned to zimmer biomet for in-depth analysis.Root cause analysis: neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the component such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.However, all possible causes related to the issues reported are listed in the dfmea which is available for every zimmer implant and is continuously monitored and updated.Conclusion summary: no medical documentation confirming the reported event were received.Moreover, no ref/lot information of the affected item was available.Therefore, 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 measures is not indicated and zimmer gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Manufacturer Narrative

Received implant stickers show that the implants are not manufactured by zimmer (b)(4).Please invalidate the case from your system.Zimmer (b)(4) will void the case.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: DUAL MODULAR STEM
• Type of Device: UNKNOWN
• 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: 6383721
• MDR Text Key: 69254771
• Report Number: 0009613350-2017-00336
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: 06/27/2017; 08/29/2017
• Supplement Dates FDA Received: 07/21/2017; 09/27/2017
• 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