MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: ncb screw; catalog no#: unknown; lot#: unknown.The manufacturer did receive per 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the left side and planned for revision surgery due to implant fracture.
Additional Manufacturer Narrative
Additional information which was received on dec 22, 2020.D11- medical product: ncb, cortical screw, self-tapping, 4.0, 46 mm; item# 0202155046; lot# unknown.Ncb, cortical screw, 5.0 mm, 44 mm; item# 0202150044; lot# unknown.Ncb, cortical screw, 5.0 mm, 32 mm; item# 0202150032; lot# unknown.Ncb, cortical screw, 5.0 mm, 42 mm; item# 0202150042; lot# unknown.Ncb, cortical screw, 5.0 mm, 34 mm; item# 0202150034; lot# unknown.Ncb, locking cap; item# 0202150300; lot# unknown.Unicortical screw 5.0 mm diameter 14 mm length warning: this device is not approved for screw attachment or fixation; item# 0202151014; lot# unknown.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 any additional information become available or 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 left side and planned for revision surgery due to implant fracture.The bone quality was very poor, because of the pseudarthrosis and therefore the plate was broken.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the product was implanted on (b)(6) 2020 and patient experienced an implant fracture without any trauma on (b)(6) 2020.A revision surgery has been planned.Patient has an existing osteoporosis condition.Review of received data: - patient information: the bone quality of the patient was very poor.In addition there was also pseudarthrosis noted.Product evaluation: - no product was returned.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 identified no deviations or anomalies during manufacturing.- raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the product was implanted on (b)(6) 2020 and patient experienced an implant fracture without any trauma on (b)(6) 2020.A revision surgery has been planned.Patient has an existing osteoporosis condition.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).No product was returned to zimmer biomet, hence visual and dimensional evaluation could not be performed.Therefore, the fracture surface analysis of the broken plate could not be done.The most possible root cause for the plate fracture is a not properly healed bone fracture.The reported event describes that the patient has osteopenic bone and that pseudarthrosis was noted.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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11088109
• Report Number: 0009613350-2020-00620
• Device Sequence Number: 14123581
• Product Code: HRS
• UDI-Device Identifier: 00889024292765
• UDI-Public: 00889024292765
• 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: 2020
• 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
• Report Date (Section B): 04/26/2021

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: 02.02263.115
• Device Lot Number: 3001849
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 12/22/2020; 04/22/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/05/2021; 04/26/2021
• 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; Required Intervention