MAUDE Adverse Event Report: ZIMMER GMBH TRAUMA IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348)

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.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

It was reported that the patient was implanted an unknown trauma implant on an unknown date.It was also reported: "the ankle fix plate was revised due to the plate fracturing.The patient was not forthcoming and was indeed still smoking a pack a day for the four months prior to the surgery.There was a non-union which caused the fracture and surgeon did not put an interfrag screw in independently of the plate.".

Manufacturer Narrative

A technical investigation was not possible to perform, as the device was not at hand.However, based on the available information the investigation is conducted with outcome as follows.It was reported that an ankle fix plate was revised due to breakage.The patient was not forthcoming and was indeed still smoking a pack a day for the four months prior to the surgery.There was a non-union which caused the fracture and the surgeon did not put an interfragmentary screw in independently of the plate.Trend analysis: n/a as no reference number was available.The dhr check could not be performed as the lot number was not available.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 components 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.The event detail describes that the plate was broken due to non union, this information was provided by the surgeon.It is not known how long the plate was in vivo.Additional information has been requested but until today no answer has been received.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.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.Zimmer's reference number of this file is (b)(4).

• Brand Name: TRAUMA IMPLANT
• 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: 6025120
• MDR Text Key: 57250269
• Report Number: 0009613350-2016-01260
• Device Sequence Number: 1
• Product Code: HSN
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

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: Health Professional
• 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
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• 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