MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Insufficient Information (4580)
Date of Event	02/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-rays and other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.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.(b)(4).
Event or Problem Description
Patient was implanted on right side and underwent revision surgery due to implant fracture.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.1.Event description: it was reported that the patient was implanted on (b)(6) 2021 with an ncb femur plate.5 weeks post surgery, patient slipped and experienced great pain in his right leg.He has subsequently fallen on the floor.X-rays revealed implant fracture.Patient underwent revision on (b)(6) 2021 for the same.Harm: s3 - bone fracture, s3 - pain or ache, moderate hazardous situation: fragments of an implant and/or bone are generated in vivo.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: the x-ray review shows the plate and the femur fractured, with the distal portion of both being displaced dorsally.Surgical report: the implantation report (dated (b)(6) 2021) has been reviewed, however no conspicuous findings relevant to the reported event have been identified.The revision report (dated (b)(6) 2021) has been reviewed and confirmation of the broken plate and femur was identified.3.Product evaluation: visual examination: the visual examination confirms the reported event; it shows that the plate fractured into two pieces.The surface of the plate was found to have small scratches.Analysis of the fracture surface identified the type of fracture as fatigue fracture.4.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 the following deviations and/or anomalies: (b)(6).Ncr(s): no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient was implanted on (b)(6) 2021 with an ncb femur plate.5 weeks post surgery, patient slipped and experienced great pain in his right leg.He has subsequently fallen on the floor.X-rays revealed implant fracture.Patient underwent revision on (b)(6) 2021 for the same.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).It is noted that the patient experienced a fall prior to the onset of pain and discovery of device fracture.However, 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).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM
• Common Device Name: 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: 11402971
• Report Number: 0009613350-2021-00108
• Device Sequence Number: 4275040
• Product Code: HRS
• UDI-Device Identifier: 00889024297562
• UDI-Public: 00889024297562
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.03264.012
• Device Lot Number: 3048091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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