MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 9 HOLES, 245 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

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

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

Medical products: ncb, locking cap; catalog#: 02.03150.300; lot#: 4503994220.Ncb, screw, self-tapping, 4.0 mm, 34 mm; catalog#: 02.03155.034; lot#: 3053723.Ncb, screw, self-tapping, 4.0 mm, 34 mm; catalog#: 02.03155.034; lot#: 3014670.Ncb, screw, self-tapping, 4.0 mm, 34 mm; catalog#: 02.03155.034; lot#: 2981839.Ncb, screw, self-tapping, 4.0 mm, 36 mm; catalog#: 02.03155.036; lot#: 3020914.Ncb, screw, self-tapping, 4.0 mm, 40 mm; catalog#: 02.03155.040; lot#: 3014688.Ncb, screw, self-tapping, 4.0 mm, 48 mm; catalog#: 02.03155.048; lot#: 2974811.Ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3039757.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.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 an unknown side and underwent a revision surgery due to implant fracture.Patient stumbled and fell that led to the fracture of the implant.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that the patient was implanted on (b)(6), 2021.The patient stumbled and fell which caused the plate to fracture hence patient underwent a revision surgery on (b)(6) 2021.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.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the patient was implanted on (b)(6),2021.The patient stumbled and fell which caused the plate to fracture hence patient underwent a revision surgery on (b)(6) 2021.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

No change to previously reported event.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 9 HOLES, 245 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
• MDR Report Key: 11561026
• MDR Text Key: 241998465
• Report Number: 0009613350-2021-00140
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297456
• UDI-Public: 00889024297456
• Combination Product (y/n): N
• PMA/PMN Number: K100111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03263.009
• Device Lot Number: 3053024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention