MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 18 HOLES, 355 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Therapy date: (b)(6) 2021.The manufacturer received x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.As no not numbers were received the device history records couldn't be reviewed.The process of gaining necessary information is still ongoing.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

Patient was implanted on an unknown side and underwent revision due to implant fracture.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: ncb, screw, 5.0, 22 mm; catalog#: 02.03150.022; lot#: unknown.Ncb, screw, 5.0, 36 mm; catalog#: 02.03150.036; lot#: unknown.Ncb, screw, 5.0, 38 mm; catalog#: 02.03150.038; lot#: unknown.Ncb, screw, 5.0, 42 mm; catalog#: 02.03150.042; lot#: unknown.Ncb, screw, 5.0, 46 mm; catalog#: 02.03150.046; lot#: unknown.Ncb, screw, 5.0, 50 mm; catalog#: 02.03150.050; lot#: unknown.Ncb, screw, 5.0, 75 mm; catalog#: 02.03150.075; lot#: unknown.Ncb, cancellous screw, 5.0 mm, 32 mm, 70 mm; catalog#: 02.03152.070; lot#: unknown.Ncb, cancellous screw, 5.0 mm, 32 mm, 75 mm; catalog#: 02.03152.075; lot#: unknown.Unicortical screw 5.0 mm diameter 14 mm length warning: this device is not approved for screw attachment or fixation; catalog#: 02.03151.014; lot#: unknown.Therapy date: sep 3, 2021.Additional information was received on oct 11, 2021.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to implant fracture.

Manufacturer Narrative

Investigation results were made available.1.Event description: it was reported that the patient came to the hospital with a broken plate approximately 4 months after surgery.Harm: s3 - bone malunion/non-union, resulting in revision or other interventions hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: radiographs were provided and reviewed by a health care professional.Review of the available records identified an incompletely healed comminuted fracture of the distal femur with some bony callus formation.Visualized portion of the plate appears to be intact.- images: review of the received image identified that the plate fractured into two pieces through a screw hole.No other damage is noted; however, the device is covered in blood.- surgical report: the surgical report from 25 may 2021 has been reviewed, however no conspicuous findings relevant to the reported event have been identified.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: - document review could not be performed due to unknown product identification.- device purpose: this device is intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.5.Conclusion: it was reported that the patient came to the hospital with a broken plate approximately 4 months after surgery.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 18 HOLES, 355 MM
• Type of Device: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12524997
• MDR Text Key: 273084553
• Report Number: 0009613350-2021-00492
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297586
• UDI-Public: 00889024297586
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K100111
• 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,Followup
• Report Date: 12/09/2021

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: 02.03264.018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/11/2021; 11/26/2021
• Supplement Dates FDA Received: 10/28/2021; 12/09/2021
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80 KG