MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3052253; ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3038385; ncb, cortical screw, 5.0 mm, 34 mm; catalog#: 02.02150.034; lot#: 3055201; ncb, cortical screw, 5.0 mm, 50 mm; catalog#: 02.02150.050; lot#: 3042101; ncb, cortical screw, 5.0 mm, 60 mm; catalog#: 02.02150.060; lot#: 3052032; ncb, cortical screw, 5.0 mm, 65 mm; catalog#: 02.02150.065; lot#: 3051305; ncb, cortical screw, 5.0 mm, 65 mm; catalog#: 02.02150.065; lot#: 3036585; ncb, cortical screw, 5.0 mm, 65 mm; catalog#: 02.02150.065; lot#: 2973779; ncb, cortical screw, 5.0 mm, 75 mm; catalog#: 02.02150.075; lot#: 2961109; ncb, cortical screw, 5.0 mm, 80 mm; catalog#: 02.02150.080; lot#: 3056483; ncb, locking cap; catalog#: 02.02150.300; lot#: 3054453; ncb, cortical screw, 5.0 mm, 42 mm; catalog#: 02.02150.042; lot#: 2974504; ncb, locking cap; catalog#: 02.02150.300; lot#: 3054280; ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3035075; ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3035079; ncb, locking cap; catalog#: 02.02150.300; lot#: 3035978; ncb, locking cap; catalog#: 02.02150.300; lot#: 3035975; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64793092; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64840101; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64793651; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64957404.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 biomets reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the left side and underwent a revision surgery due to plate fatigue.The patient fell onto her right side while closing the curtains.X-rays revealed abundance of callus formation, non union of previous fracture and fatigue failure of the plate.
Additional Manufacturer Narrative
1.Event description: it was reported that the patient fell on their right side.X-rays revealed abundance of callus formation, non-union of a previous fracture, and fracture of the plate.The patient then underwent revision surgery.Harm: s3 - bone malunion/non-union, resulting in revision or other interventions 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.- radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the plate is fractured and mildly displaced.There is also mild angulation at the femur fracture site apex lateral.There is prominent callus formation of the medial femoral diaphyseal fracture site with fracture lucencies present.Bone quality is also noted as osteopenic.3.Product evaluation: - visual examination: the visual examination confirms the reported event; it shows that the plate is fractured, with both pieces returned.Analysis of the fracture surface identified the fracture as a fatigue fracture.The plate surfaces also have scratches and wear.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified the following deviations and/or anomalies: (b)(4).- ncr(s): no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient fell on their right side.X-rays revealed abundance of callus formation, non-union of a previous fracture, and fracture of the plate.The patient then underwent revision surgery.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 non-conformance or a complaint out of box (coob).It is noted that the patient experienced a fall prior to the radiographs revealing the plate fracture.However, 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 or Problem Description
Investigation results are now available.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 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
• 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: 12330273
• Report Number: 0009613350-2021-00409
• Device Sequence Number: 4686637
• Product Code: HRS
• UDI-Device Identifier: 00889024292901
• UDI-Public: 00889024292901
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02264.115
• Device Lot Number: 2952347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG