MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB SCREW, 5.0, 80 MM; NCB PLATING SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: ncb femur plate, left, 5 holes, 167 mm; catalog#: 02.03260.105; lot#: unknown; ncb screw, 5.0, 36 mm; catalog#: 02.03150.036; lot#: unknown; ncb screw, 5.0, 50 mm; catalog#: 02.03150.050; lot#: unknown; ncb screw, 5.0, 85 mm; catalog#: 02.03150.085; lot#: unknown; ncb locking cap; catalog#: 02.03150.300; lot#: unknown; ncb cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: unknown; cable cerclage cable with crimp 1.8 mm dia.635 mm length; catalog#: 00-2232-004-18; lot#: unknown; ncb drill bit, 4.3 mm, 145 mm; catalog#: 02.00024.001; lot#: unknown; kirschner wire with trocar tip, 2 mm, 280 mm; catalog#: 290.20.280; lot#: unknown.Therapy date: (b)(6) 2021.The manufacturer did receive a per, images of explants and implant incident report with x-rays, intra-op pictures 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
Patient was implanted on the right side and underwent revision surgery due to periprosthetic fracture, migration of the plate, screw fracture and wear.
Additional Manufacturer Narrative
D10: medical products: ncb femur plate, left, 5 holes, 167 mm; catalog#: 02.03260.105; lot#: 3007424, ncb screw, 5.0, 36 mm; catalog#: 02.03150.036; lot#: unknown, ncb screw, 5.0, 50 mm; catalog#: 02.03150.050; lot#: unknown, ncb screw, 5.0, 85 mm; catalog#: 02.03150.085; lot#: unknown, ncb locking cap; catalog#: 02.03150.300; lot#: unknown, ncb cable button for ncb polyaxial locking plate, 2.5 mm hex drive catalog#: 47-2232-060-01; lot#: unknown, cable cerclage cable with crimp 1.8 mm dia.635 mm length catalog#: 00-2232-004-18; lot#: unknown, ncb drill bit, 4.3 mm, 145 mm; catalog#: 02.00024.001; lot#: unknown, kirschner wire with trocar tip, 2 mm, 280 mm; catalog#: 290.20.280; lot#: unknown.Therapy date: (b)(6) 2021.Additional information was received on mar 3, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Correction: b4, b5, b7, g3, g6, h2, h10.The manufacturer received other source documents 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).
Event or Problem Description
Patient was implanted on the right side and underwent a revision surgery due to periprosthetic fracture, implant fracture and wear between the two distal screws and the ncb plate leading to the migration of the ncb plate.It was also noted that hip gave away after light exercise on (b)(6) 2021 without any trauma or fall.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
This device has been now added to the associated products (section d10 in corresponding medwatches) as it is not event related according to the investigation results.Please delete this medwatch from your records.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to periprosthetic fracture, migration of the plate, screw fracture and wear.
Additional Manufacturer Narrative
Additional information which was received on feb 22, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents 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).

• Brand Name: NCB SCREW, 5.0, 80 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: 11341596
• Report Number: 0009613350-2021-00092
• Device Sequence Number: 14711385
• Product Code: HRS
• UDI-Device Identifier: 00889024295872
• UDI-Public: 00889024295872
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 08/11/2021

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: 02.03150.080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/22/2021; 03/03/2021; 07/23/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/09/2021; 03/12/2021; 08/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 89