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

Model Number N/A

Device Problems Fracture (1260); Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Concomitant medical products:: medical product: ncb, screw, 5.0, 42 mm; item# 0203150042; lot# unknown; ncb, screw, 5.0, 44 mm; item# 0203150044; lot# unknown; ncb, screw,¸ 5.0, 50 mm; item# 0203150050; lot# unknown; ncb, screw, self-tapping, 4.0 mm, 38 mm; item# 0203155038; lot# unknown; ncb, screw, self-tapping, 4.0 mm, 40 mm; item# 0203155040; lot# unknown; ncb, screw, self-tapping,¸ 4.0 mm, 42 mm; item# 0203155042; lot# unknown; ncb, locking cap; item# 0203150300; lot# unknown; unknown; item# 2232-001-18; lot# unknown.The manufacturer received x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.As no lot numbers were provided the device history records couldn't be reviewed.The process of gaining necessary information is still ongoing.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 Description

Patient was implanted on the left side and underwent revision due to implant fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient came to hospital with a broken plate approximately 6 months after surgery.The patient claims that the plate was broken when moving his leg out of bed.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: three x-ray pictures were available.The x-ray review shows that the ncb pp plate is broken through the middle screw hole of a three hole pattern.An existing hip prosthesis can also be seen.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.Conclusion: it was reported that the patient came to hospital with a broken plate approximately 6 months after surgery.The patient claims that the plate was broken when moving his leg out of bed.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part(s) is unknown.The provided x-rays confirm the reported event.It can be asssumed that the ncb pp plate was broken after 6 months due to fatigue.Fatigue fractures can occur due to a cyclic overloading.Possible contributing factors to the overload could be a not properly healed bone fracture and / or not adherence to the postoperative protocol (patient behavior).The investigation did not identify a nonconformance or a complaint out of box (coob).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).

Event Description

No change to previously reported event.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
• Type of Device: INTERNAL ORTHOPAEDIC FIXATION SYSTEM
• 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: 12546474
• MDR Text Key: 273779231
• Report Number: 0009613350-2021-00505
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297524
• UDI-Public: 00889024297524
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03263.115
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 70 KG