MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC TROCHANTER PLATE, RIGHT, NARROW; NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-ray for review.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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and experienced implant fracture.The patient has been scheduled for a revision surgery.
Event or Problem Description
Patient was implanted on the right side and experienced implant fracture.Patient does not want to have a revision surgery as she did not have any accident since the plate was implanted.Hence no revision has taken place yet.
Additional Manufacturer Narrative
Additional information which was received on jul 20, 2020.Additionals: b5.Corrections: b4, g4, g7, h10.The manufacturer received x-ray for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that patient is a an 82 year female who had an implant surgery on (b)(6) 2019.Subsequently patient experienced an implant fracture and is scheduled for revision in (b)(6) 2020 (unknown date).Review of received data: x-rays: the received x-ray was reviewed and confirms the breakage of the ncb pp plate.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 could not be performed as only the complained product is known.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: no product was returned as the product remains implanted, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part(s) is unknown.Based on the provided x-ray 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).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 or Problem Description
Investigation has been completed.

• Brand Name: NCB, PERIPROSTHETIC TROCHANTER PLATE, RIGHT, NARROW
• Common Device Name: NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10167380
• Report Number: 0009613350-2020-00264
• Device Sequence Number: 2153003
• Product Code: HRS
• UDI-Device Identifier: 00889024292796
• UDI-Public: 00889024292796
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K120772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020

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: 02.02263.201
• Device Lot Number: 2959756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 10/21/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/23/2020; 11/04/2020
• 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
• Patient Age: 82 YR