MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCBA, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM; PLATE, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right implant revision approximately 6 months post-op due to an implant fracture.No further information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: div.Schrauben: item# unknown; lot# unknown.Klemmschrauben: item# unknown; lot# unknown.Cerclagen: item# unknown; lot# unknown.Report source: foreign - germany.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, d2, d4, d9, g3, g6, h1, h2, h3, h6, h10.Visual examination: the broken ncb plate was returned for investigation together with screws, cerclage cables and locking cups.The plate was broken into two parts.The fracture of the plate is located through a screw hole.On the fracture surfaces, beach lines are visible which point to a possible fatigue fracture failure.The fracture surfaces show also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Some scratches are visible on the surface of the non-bone-facing side of the plate.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.With the available data it is not possible to establish a definitive root cause for the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NCBA, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM
• Common Device Name: PLATE, FIXATION
• 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: 14692535
• Report Number: 0009613350-2022-00335
• Device Sequence Number: 5465345
• Product Code: HRS
• UDI-Device Identifier: 00889024297388
• UDI-Public: (01)00889024297388(11)130521(10)2710830
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 02.03260.013
• Device Lot Number: 2710830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 53 KG