MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 18 HOLES, 363 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994); Insufficient Information (4580)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

Medical products: ncb pp troch plate left wide; catalog#: 02.02263.302; lot#: 2999155.Genieric - ncb kortikalisschrauben 5.0; catalog#: unknown; lot#: unknown.Genieric - ncb kortikalisschrauben 4.0; catalog#: unknown; lot#: unknown.Genieric - kortikalisschrauben 3.5; catalog#: unknown; lot#: unknown.Genieric - ncb verschlusskappen; catalog#: unknown; lot#: unknown.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.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 the left side and underwent a revision surgery due to implant fracture.

Event Description

Patient was implanted on the left side and heard a crack while walking with the rollator and started experiencing pain.Hence, the patient underwent a revision surgery due to pain and implant fracture.

Manufacturer Narrative

D10: medical products: ncb pp troch plate left wide; catalog#: 02.02263.302; lot#: 2999155 genieric - ncb kortikalisschrauben 5.0; catalog#: unknown; lot#: unknown.Genieric - ncb kortikalisschrauben 4.0; catalog#: unknown; lot#: unknown.Genieric - kortikalisschrauben 3.5; catalog#: unknown; lot#: unknown.Genieric - ncb verschlusskappen; catalog#: unknown; lot#: unknown.Therapy date: (b)(6) 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on aug 25, 2021.The manufacturer received other source documents (surgical reports) 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).

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was implanted with a ncb periprosthetic plate on (b)(6) 2021 and underwent revision on (b)(6) 2021 due to implant fracture.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: the x-rays were reviewed but not sent for further analysis as revision op records are provided and give a sufficient findings of the event.Surgical report: the surgical report dated (b)(6) 2021 has been reviewed, however no conspicuous findings relevant to the reported event have been identified.Review of the surgical report dated (b)(6) 2021 identified that the plate was fractured and removed.There was callus formation on the medial side and the proximal fracture was completely consolidated.A new plate was implanted.Product evaluation: visual examination: the visual examination confirms the reported event; it shows that the femoral plate fractured into 2 pieces through a screw hole.On the fracture surfaces, beach lines are visible under certain light condition which point to a fatigue fracture.Macroscopic examination showed no defects that could trigger or contribute to the fracture.The plate shows several slight scratches.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified one deviations and/or anomalies: ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient was implanted with a ncb periprosthetic plate on (b)(6) 2021 and underwent revision on (b)(6) 2021 due to implant fracture.Based on the investigation the reported event can be confirmed.The visual examination shows that the femur plate fractured into 2 pieces through a screw hole.The visual examination of the plate indicates a fatigue fracture.Device fracture is a known adverse event and per the instructions for use -the risk of adverse effects such as secondary infections, allergies, material fatigue (breakage), implant failure and/or impaired blood circulation increases with the time the implant is implanted, delayed union, non-union, patient weight and activity level.- if and to what extend any of these factors may have caused or contributed to the implant fractured cannot be determined based on the available information.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the available information and performed investigation, an exact root cause for the plate breakage could not be determined.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

No change to previously reported event.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 18 HOLES, 363 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: 12275321
• MDR Text Key: 265058200
• Report Number: 0009613350-2021-00371
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297531
• UDI-Public: 00889024297531
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 02.03263.118
• Device Lot Number: 3045829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• 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: 85 YR
• Patient Sex: Male