MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM; NCB PERIPROSTHETIC DISTAL FEMUR PLATE, RIGHT, UNSTERILE,12 HOLES, L. 278 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-ray for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 an unknown side and underwent revision surgery due to implant fracture.
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2019.The manufacturer received x-rays for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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
No event update.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2,h4 h6.Correction: b4, d1, d4, g4, g7, h3, h10.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Part specific investigation: less than 3 similar investigated events within the last 1 month and less than 6 similar investigated events within the last 6 months prior to the event date have been found for this item number.Result: issue evaluation request is not required.Lot specific investigation: less than 3 similar investigated events for the same lot number have been found.Result: issue evaluation request is not required.Review of event description: it was reported that the implant was found to be fractured.Revision performed on (b)(6) 2019.Review of received data: assessment of imaging: three images of the left femur dated (b)(6) 2019 demonstrate a left total hip arthroplasty in place.There is placement of a lateral plate and screw fixation device with six proximal surgical screws and approximate five distal screws.There are two cerclage wires present along the mid to distal femoral diaphysis with evidence of a comminuted fracture of the mid to distal femoral diaphysis.Surgical skin staples in place, suggesting recent surgery.Left total knee arthroplasty, incompletely evaluated.Two views of the left femur dated (b)(6) 2019 demonstrate a fractured lateral from a plate at the distal diaphysis in the region of the distal cerclage wire.Persistent comminuted fracture is present with bony calcination but listen fracture line still seen.Devices analysis: visual examination: the ncb pp plate was returned for investigation.The plate is fractured into two parts.The fracture of the plate is located through a three hole pattern.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.The fracture surfaces shows also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Several scratches are visible on the surface of the plate.Review of product documentation: this device is intended for treatment.Raw material certificate was reviewed and is according to specification.Conclusion summary: it was reported that the patient had a revision surgery due to a ncb pp plate fracture.The plate was in vivo for approximately 3 months.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the ncb pp plate have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance 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.However, 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 gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM
• Common Device Name: NCB PERIPROSTHETIC DISTAL FEMUR PLATE, RIGHT, UNSTERILE,12 HOLES, L. 278 MM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9409276
• Report Number: 0009613350-2019-00763
• Device Sequence Number: 1834634
• Product Code: HRS
• UDI-Device Identifier: 00889024297562
• UDI-Public: 00889024297562
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100111
• 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): 03/13/2020

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: 0202264115
• Device Lot Number: 2989812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 03/03/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/10/2019; 03/13/2020
• 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: 81 YR