MAUDE Adverse Event Report: ZIMMER GMBH NCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did receive x-rays 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 or Problem Description
Patient was implanted on the left side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Additional information was received on may 04,2020.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No changes.
Event or Problem Description
Investigation completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the product was implanted on (b)(6) 2019 and revised on (b)(6) 2019 due to implant fracture.Review of received data: x-rays: the x-ray dated (b)(6) 2019 confirms the breakage of the ncb plate.Product evaluation: visual examination: the ncb plate was returned for investigation.The plate is fractured into two parts.The fracture of the plate is located through a hole.On the fracture surfaces, beach lines are visible which point to a fatigue fracture starting from the non-bone facing side.The fracture surfaces shows also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Macroscopically nothing that could have triggered or contributed to the fracture was observed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet, see surgical technique.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 product was implanted on (b)(6) 2019 and revised on (b)(6) 2019 due to implant fracture.Based on the investigation the reported event can be confirmed.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).The visual examination of the plate indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Fatigue fractures occur due to a cyclic overloading.Possible contributing factors to the overload could be wrong patient behaviour and / or a not properly healed bone fracture.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 gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9835453
• Report Number: 0009613350-2020-00131
• Device Sequence Number: 1212823
• Product Code: HRS
• UDI-Device Identifier: 00889024297401
• UDI-Public: 00889024297401
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03260.109
• Device Lot Number: 2961694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 08/12/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 06/02/2020; 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 58