MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB SCREW, 5.0, 40 MM; NCB PLATING SYSTEM

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received other source documents for review.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 after implantation the patient started experiencing pain, extreme swelling and limited range of motion.Patient gained weight post implantation.Hence, the patient went for second opinion and from the x-rays it was told to her that the screws were too long and there were no end caps on the screws.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that patient had a distal femur fracture which was treated with ncba periprosthetic femur plate.Post-implantation the patient started experiencing pain, extreme swelling around her knee and limited range of motion.Review of received data: no medical data relevant to the case has been received.- x-rays: images were provided which are a xeroxed copy of actual x-ray and are grainy and of poor quality.Therefore, an assessment was not possible.Product evaluation: no product was returned as it remains implanted; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: review of the device history records could not be performed as the lot numbers of the devices were not available.- instruction for use (ifu): the applicable instruction for use (ifu) was reviewed with no anomalies noted.Conclusion: it was reported that patient had a distal femur fracture which was treated with ncba periprosthetic femur plate.Post-implantation the patient started experiencing pain, extreme swelling around her knee and limited range of motion.Neither operative notes, office visit notes, nor device(s) or photos of the device(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the investigation the reported event cannot be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or 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).The following reports are associated with this event: 0009613350-2021-00043-1, 0009613350-2021-00045-1, 0009613350-2021-00046-1, 0009613350-2021-00044-1, 0009613350-2021-00041-1, 0009613350-2021-00047-1, and 0009613350-2021-00042-1.

• Brand Name: NCB SCREW, 5.0, 40 MM
• Common Device Name: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11242732
• Report Number: 0009613350-2021-00040
• Device Sequence Number: 17033237
• Product Code: HRS
• UDI-Device Identifier: 00889024295766
• UDI-Public: 00889024295766
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03150.040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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
• Patient Weight: 113