MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 9 HOLES, 238 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ncb, screw¸ 5.0, 34 mm, catalog no#:0203150034, lot#: 2966025.Ncb, screw¸ 5.0, 34 mm, catalog no#:0203150034, lot#: 2969414.Ncb, screw¸ 5.0, 34 mm, catalog no#:0203150034, lot#: 2972677.Ncb, cancellous screw¸ 5.0 mm, 32 mm, 50 mm, catalog no#:0203152060, lot#: 4502494638.Ncb, cancellous screw¸ 5.0 mm, 32 mm, 70 mm, catalog no#:0203152070, lot#: 4502598475.Ncb, cancellous screw¸ 5.0 mm, 32 mm, 75 mm, catalog no#:0203152075, lot#: 4502530997.Ncb, cancellous screw¸ 5.0 mm, 32 mm, 50 mm, catalog no#:0203152050, lot#: 4502376179.Therapy date : (b)(6) 2019.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the explanted 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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Additional information which was received on (b)(6) 2019 this follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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 revision surgery due to implant fracture.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was implanted with a ncb periprosthetic femur plate on (b)(6) 2019 and underwent a revision surgery on (b)(6) 2019 due to fracture occurred on (b)(6) 2019.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: nine x-ray pictures are available for investigation.These are dated between (b)(6) 2019.2 x-rays dated (b)(6) 2019: knee joint with distal thigh and proximal lower leg, ap-/lateral-view: spiral fracture recognizable in the ap view, reaching up to the level of the femoral prosthesis component.In the lateral view also recognizable fracture extended up to the level of the femoral prosthesis component.Fracture visible at the level of the caudal third of the patella.2 x-rays dated (b)(6) 2019: knee joint with distal thigh and proximal lower leg, ap-/lateral-view: situation after osteosynthesis using the ncb plate and three cable wires at the level of the fracture zone.The fracture appears well and correctly reduced in the ap-view.In the lateral view the bony structures dorsal to the plate at the level of the fracture zone are not visible due to the exposure.2 x-rays dated (b)(6) 2019: knee joint with distal thigh and proximal lower leg, ap-/lateral-view: recognizable break of the plate just above the middle cerclage wire at the level of an unoccupied screw hole.In the area of the fracture zones there was no evidence of bony healing.1 x-ray dated (b)(6) 2019: knee joint with distal thigh and proximal lower leg, ap-view: situation after re-osteosynthesis with a recognizable fracture zone.2 undated x-rays: knee joint with distal thigh and proximal lower leg, ap-/lateral-view: situation after osteosynthesis using the ncb plate and three cable wires.The fracture zone with several bony fragments is clear visible.In the lateral view the bony structures dorsal to the plate at the level of the fracture zone are not visible.- surgical report: the surgical report of implantation and the surgical report of the revision is available.Surgical report of implantation dated (b)(6) 2019: it is stated that an ncb pp plate with several screws and 3 cerclage wires were implanted to treat the fracture.A good stability and fixation was achieved despite osteoporotic bone.No conspicuous findings relevant to the reported event have been identified.Surgical report of revision dated (b)(6) 2019: the broken ncb pp plate was removed and replaced with a new ncb pp plate.A good fixation of the components and good fracture reduction is 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 patient was implanted with a ncb periprosthetic femur plate on (b)(6) 2019 and underwent a revision surgery on (b)(6) 2019 due to fracture occurred on (b)(6) 2019.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).Several x-rays and surgical reports were received.The x-rays confirm the breakage of the ncb pp plate.It was also noted in the surgical report dated april 09, 2019 that the patient has osteoporotic bone.As no product was returned to zimmer biomet for in-depth analysis, the fracture surfaces of the broken ncb pp plate could not be evaluated.Considering the patient's age, the surgeon's intraoperative notes dated (b)(6) 2019 about osteoporotic bone conditions are absolutely plausible.In osteoporosis, bone-fracture healing is impaired or slowed down.From a medical point of view, taking into account the available radiological findings, delayed or impaired fracture healing may have contributed to the fracture of the plate.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 gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 9 HOLES, 238 MM
• Common Device Name: NCB, PERIPROSTHETIC FEMUR PLATE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8900427
• Report Number: 0009613350-2019-00492
• Device Sequence Number: 253366
• Product Code: HRS
• UDI-Device Identifier: 00889024297555
• UDI-Public: 00889024297555
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K1001111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2020

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: 02.03264.009
• Device Lot Number: 2961111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 09/28/2020
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 12/11/2019; 09/28/2020
• 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
• Patient Weight: 63