MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN NCB PP PLATE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Osteolysis (2377); Post Operative Wound Infection (2446)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.Surgical reports were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

A patient is pursuing a product liability claim.It was reported that the patient was implanted an unknown ncb pp plate on the left thigh on (b)(6) 2015.Subsequently, patient underwent irrigation and debridement on (b)(6) 2015 due to persistant wound drainage that occurred post-operatively.

Manufacturer Narrative

Additional information has been requested and is currently not available.No trend analysis could be performed as no item number is available.Event summary: it was reported that a patient underwent initial extremity procedure on (b)(6) 2015 and on (b)(6) 2015 patient experienced persistently draining wound, left thigh, status post open reduction internal fixation of complex femur fracture.Irrigation and debridement on left thigh.The plate breakage is considered in complaint (b)(4).Review of received data: there were 6 pictures of the plate provided.On the pictures the broken plate can be seen.The fracture is located in the middle hole of the first three hole pattern (seen from proximal).In addition, 11 screws can be seen.The screws were used to fix the plate.No abnormality detected on the screws.This results are already in complaint (b)(4) available.Review of surgical report 13.08.2015: diagnosis: left periprosthetic supracondylar femur fracture with midshaft extension.Procedure: the ncb pp plate was implanted in good position.Several screws were used to fix the plate.In addition, cerclage cables were used.In general good reduction of the fracture, good position of the implants.Review of surgical report 03.02.2016: diagnosis: left femur fracture non-union with hardware failure.Procedure: the broken plate and screw were removed.It was noted that the patient¿s bone was extremely osteoporotic and there was gross motion at part of the fracture.There was definite non-healing of the mid-portion.After the removal of the plate and screws, an intramedullary nail was implanted (unknown manufacturer).In general no intraoperative complications occurred.Finally it was noted that the patient is morbidly obese and overall poor bone quality.A legal documentation was received.In that documentation it is noticed that the patient had passed away.No other relevant information found for the investigation in the received legal documentation.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Root cause analysis: root cause determination using rmw: failure of surgery due to wrong selection of components or use in combination with device outside the system not possible- no issue with the combination of the components.Failure of surgery due to use of the device not compliant with defined indications not possible -> no indication issue.Failure of surgery due to missing/incomplete information available, misleading information of surgical technique or instruction of use => possible, it is possible that the surgeon was not aware of all relevant information.Failure of surgery due to wrong/misleading information of labels not possible -> no label issue known.Failure of surgery due to insufficient warning of side effects => possible, as no specific information was provided for draining wound, this point cannot be excluded.Conclusion summary: it was reported that a patient underwent initial extremity procedure on (b)(6) 2015 and on (b)(6) 2015 patient experienced persistently draining wound, left thigh, status post open reduction internal fixation of complex femur fracture.Irrigation and debridement on left thigh.This complaint was created for draining wound.The plate breakage is considered in complaint (b)(4).No further specific information for draining wound available.The revision surgery was performed on (b)(6) 2016 due to plate breakage.Unfortunately, on (b)(6) 2017 it was noticed that the patient had passed away.However, the cause or date of her death was not provided.No other information is available.No correlation between the products reported in this complaint and the patient death.However, an exact root cause could not be determined.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).

• Brand Name: UNKNOWN NCB PP PLATE
• Type of Device: UNKNOWN NCB PP PLATE
• 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: 6867872
• MDR Text Key: 86251842
• Report Number: 0009613350-2017-01229
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• 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: UNK.
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• 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
• Patient Age: 72 YR
• Patient Weight: 102