MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Implant Pain (4561); Insufficient Information (4580)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.Lot numbers were received and the device history records were reviewed and found to be conforming.The manufacturer did not receive the device for investigation.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 an unknown side and underwent revision due to implant fracture.

Manufacturer Narrative

Additional information was received on apr 26, 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 x-rays and 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 Description

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

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that znn nail fractured and was revised on (b)(6) 2021.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: right hip ap-view preoperatively dated on (b)(6) 2020: situation after dislocated per- and sub-trochanteric left femoral fracture.The proximal part is tilted medially, therefore the lower part of the bony fragment protrudes laterally.Pelvic overview postoperatively dated on (b)(6) 2020: situation after osteosynthesis with a znn nail.The broken lesser trochanter fragment can be seen medially below the lag screw (marked in blue).In this area there is a larger osseous substance defect (marked in yellow).Below the entry point of the lag screw laterally, there is a clear lateral dislocation of the lower part of the proximal fragment (marked in red).Pelvic overview and second view dated on (b)(6) 2021: compared to the previous follow-up, the osseous substance defect zone medially below the lag screw (marked in yellow) seems to be unchanged.Also the lower part of the proximal fragment laterally is displaced almost unchanged (marked in red) without any discernible evidence of bony healing (marked in green).The proximal part of the nail above the lag screw is slightly tilted medially.Surgical report: a pdf in french was received with some medical records.Surgical report dated (b)(6) 2020: diagnosis: complex per- and sub-trochanteric left femoral fracture.Indication: osteosynthesis with znn nail.Surgical procedure: implantation of a znn nail diameter 10, 125°, 21.5 cm length and removal of the guide wire.Insertion of a 95 mm lag screw.Locking of the screw after compression of the fracture area.Distal static locking with a 35mm screw.Doctor¿s letter dated (b)(6) 2020: female patient, 76 years old, was admitted to the hospital following a per- and sub-trochanteric left femoral fracture due to a mechanical fall.The patient is living with her husband and was walking without crutches.Weight 82 kg, height: 1.62 m.Patient history: overweight surgical background: fracture reduction with znn nail on (b)(6) 2020.The results of a vascular echo-doppler examination on (b)(6) 2020 pointed to a thrombo-phlebitis of the left soleus muscle.Doctor¿s letter dated (b)(6) 2021: left femoral fracture in (b)(6) 2020, osteosynthesis with short znn nail.On (b)(6) 2021, the patient experienced a sudden pain in the left hip with impossibility to move.Upon arrival to the emergencies x-rays showed a fracture on pseudoarthrosis with a presumed broken nail at the lag screw level.Surgical procedure: removal without difficulties of the lag screw.Removal without difficulties of the distal locking screw.There is an osseous slab on the lateral side of the proximal femur with complete pseudoarthrosis and reduction failure.The distal part of the nail was removed with difficulties.With the help of an osteotome and a gouge, an abrasion of the pseudoarthrosis edges was performed.Osseous decortication of the fracture¿s periphery leaving the pedicle muscle on the bone fragments.Doctor¿s letter dated on (b)(6) 2021: admission to the hospital on (b)(6) 2021 with impossibility to move due to broken nail.Revision surgery on (b)(6) 2021: removal of the broken nail and implantation of a long nail associated with an osseous decortication in the proximal fracture region.Cerclage wires were used for stabilization.Product evaluation: visual examination: the broken znn nail and sub components were returned for investigation.The nail was broken into two fragments.Both fracture surfaces point to fatigue starting from the lateral side of the nail.Marks from the drill, polishing from contact with the lag screw and damage from revision can also be observed.On the proximal fracture part of the nail there is a crack starting from the corner of one of the fracture surfaces and running to proximal approximately 5 mm.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed and showed that 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 had a revision surgery due to a znn nail fracture.The nail was in vivo for approximately 5 months.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the znn nail have met the specifications valid at the time of production.The provided medical records confirm a reduction failure of the fracture.This reduction failure has contributed to the fact that no osseous healing of the fracture took place after primary osteosynthesis and therefore a non-union of the fracture has developed.The visual examination of the returned nail indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.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 above mentioned non-union could have led to the nail breakage after 5 months of implantation.However, based on the available information and performed investigation, an exact root cause for the nail breakage could not be determined.The investigation results did not identify a non-conformance or a complaint out of box (coob).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

Investigation has been completed.

• Brand Name: CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11397477
• MDR Text Key: 234208894
• Report Number: 0009613350-2021-00115
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298873
• UDI-Public: 00889024298873
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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: 47-2493-211-10
• Device Lot Number: 3012457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 82