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Concomitant medical product: ncb, cancellous screw, 5.0, 90 mm; item # 0203152090; lot # unknown, ncb, screw, 5.0, 32 mm; item # 0203150032; lot # unknown, ncb, cancellous screw, 5.0 mm, 32 mm, 85 mm; item # 0203152085; lot # unknown, ncb, screw, 5.0, 34 mm; item # 0203150034; lot # unknown, ncb, screw, 5.0, 30 mm; item # 0203150030; lot # unknown, ncb, screw, 5.0, 50 mm; item # 0203150050; lot # unknown, ncb, screw, 5.0, 55 mm; item # 0203150055; lot # unknown, ncb, screw, 5.0, 36 mm; item # 0203150036; lot # unknown, ncb, cancellous screw, 5.0 mm, 32 mm, 80 mm; item # 0203152080; lot # unknown, ncb, screw, 5.0, 40 mm; item # 0203150040; lot # unknown, ncb, locking cap; item # 0203150300; lot # unknown, depuy synthes cerclage wire; item # unknown; lot # unknown.The manufacturer received x-rays and other source documents which will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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).
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Investigation results were made available.Additional: d4, h2, h6, correction: b4, b5, g4, g7, h10.Event description: the female patient (b)(6) experienced a fracture of the left femur on (b)(6), 2018, which was treated with a ncb plate on the same day at kuk linz.On , 2019 the patient underwent a revision surgery due to plate and periosteosynthetic femur fracture (b)(4).On (b)(6), 2019 the patient was admitted to emergency again due to ncb plate and periosteosynthetic femur fracture.Followed by a revision surgery consisting of osteosynthesis and spongiosaplasty on (b)(6)2019 (b)(4).This complaint concerns the components that were revised on (b)(6) 2019.Review of received data: letter from the consumer advisory board oö (konsumentenberatung oö), dated (b)(6) 2020: please note, this is a summary of the letter which was translated from german to english.The surgeon was informed by the advisory board that the ncb plate with which the patient (b)(6).Was supplied with on (b)(6), 2019 fractured on (b)(6) 2019 for no apparent reason.The patient was again hospitalized at (b)(6) and underwent a revision surgery on (b)(6) 2019 where the patient was implanted with a new metal plate which was reinforced with donor bone.The patient was transferred to the remobilization department on (b)(6), 2019 and discharged home on (b)(6), 2019.The patient was stationary at the rehabilitation center (b)(6) from (b)(6), 2020 to (b)(6), 2020.Back home the patient still requires support in personal hygiene, household care and shopping.Review of received medical records: please note, all received medical records were translated from german to english and information relevant to the case was summarized.Post-treatment report (b)(6))from the (b)(6), covering the period from (b)(6) 2018 to (b)(6)2020: (b)(6) 2018, 6 weeks visit: fractured femur treated with osteosynthesis.Osteosynthesis material in-situ without indication of loosening.(b)(6)2019, 3 months visit: osteosynthesis with correct placement, no indication of loosening or implant failure.Beginning of bony consolidation, however, fracture still well visible.(b)(6) 2019: periosteosynthetic femur fracture left (plate fracture).Surgical treatment on (b)(6) 2019.(b)(6)2019: osteosynthesis in-situ, no indication of loosening.Appearance of callus formation and differential diagnosis of cement in the area of the fracture.Weight-bearing can be increased to 30 kg.(b)(6) 2019, 9 weeks visit: progressive fracture healing of the periosteosynthetic fracture with rever-plating.Adequate callus formation.Patient is free of pain.(b)(6) 2019: increasing callus formation, no indication of loosening, no dynamic.The patient is increasingly mobile thanks to the walker.(b)(6) 2019, 6 months visit: osteosynthesis properly in-situ, increasing fracture consolidation.Patient does not require crutches at home, outdoor she uses one crutch.(b)(6) 2019: patient admitted to emergency due to strong pain without rememberable trauma in the left femur and in the knee.Radiologically visible plate fracture on the left.No indication of a fracture at the diaphysis in the previous images taken 2.5 weeks ago.(b)(6) 2019, 6 weeks visit: no radiological changes since previous images.The patient is doing well, weight-bearing up to 10 kg until 8 weeks postoperative.(b)(6) 2019, 3 months visit: patient arrives in wheelchair, until no partial loading to 20 kg.Clearly visible callus formation in the area of the re-refracture.No indication of an implant failure or rupture of a cerclage wire.Start to increase weight-bearing.(b)(6) 2020: increasing callus formation in the area of the osteosynthesis with foreign cortical bone.No plate fracture.Start of rehabilitation in clinic bad schallerbach.(b)(6) 2020: patient is free of complaint.Radiologically, advanced bone remodeling with advanced bony consolidation.Donor bone not resorbed, still tightly fitting without significant bony consolidation.An axial stabilization is expected.The two surgical care documents (op-pflegedokument) from (b)(6) from the surgeries of (b)(6), 2018 (op no.(b)(6)) and (b)(6), 2019 (op no.(b)(6)) do not contain additional case relevant information.Ct examination, dated (b)(6) 2019: findings: fracture of the osteosynthetic material in the left femur with insufficient bony consolidation of the known fracture in the distal third of the femoral shaft.Otherwise, no other recent trauma-associated changes identified.Degenerative changes medially at the knee joint.Surgical report (b)(6), dated (b)(6) 2019: diagnosis: plate fracture due to pseudoarthrosis condition after femoral fracture in the area of the stem and hip endoprosthesis.Treatment: osteosynthesis and spongiosaplasty description of procedure: incision in the area of the scar.Scar tissue at the plate.Removal of the screws and the plate.Dead femur in the area of the fracture, little vitality.Decortication.In the defect zone a crumbly mass is removed, probably bone cement from the previous surgery.Reposition of the fracture and osteosynthesis.Surgical care documents (op-pflegedokument) from the (b)(6) from the surgery dated (b)(6), 2019 (op no.(b)(6)): preoperative skin changes: excoriation of left body trunk.Histology report, signed (b)(6) 2019: diagnosis: abundant avital material and detritus precipitation.Patient transfer records, signed (b)(6) 2019 ((b)(6)and (b)(6) 2019 ((b)(6): anamnesis: patient admitted to emergency due to left femur osteosynthetic and periosteosynthetic fracture.No memorable trauma, now again strong pain in the left femur.Treatment: osteosynthesis and spongiosaplasty on (b)(6) 2019.Medical history: the patient was admitted on (b)(6)2019 with strong pain in the left femur for ct examination, surgical treatment and subsequent stationary stay.Findings: periosteosynthetic fracture of left femur and plate fracture.Surgical treatment on (b)(6) 2019.Resolved postoperative anaemia and treatment of permanent atrial fibrillation.The radiological controls have shown no complications.Wound swab taken on (b)(6) (due to increased wound secretion) revealed a staph.Epidermidis accumulation, which had no therapeutic consequence.The fractured plate was handed over to the patient.Physician letter, signed (b)(6), 2019 (ass.(b)(6).): diagnosis: re-refracture osteosynthesis left femur, condition after periprosthetic femur fracture left ((b)(6) 2018), condition after implant fracture (osteosynthesis (b)(6) 2019).Medical history: postoperative anaemia, permanent atrial fibrillation, tachycardiac episode postop., osteoporosis, art.Hypertension, diabetes mellitus type ii, rheumatoid arthritis, hyperuricemia, lat.Hyperthyroidism, carcinoma (removed (b)(6)2 019), bilateral htep (1992/1997).Summary of stationary stay: the patient was admitted for further remobilization on (b)(6) 2019 after osteosynthesis and spongiosaplasty of the left femur, performed on( b)(6) 2019.Weight-bearing of 10kg allowed 12-18 weeks postoperatively.Swelling in the surgical area, without signs of infection.Patient was discharged from stationary stay on (b)(6) 2019.X-ray: the following x-ray analysis has been performed by a health care professional (hcp): (b)(6) 2019: periosteal callus formation, fracture lines clearly visible.Evidence of incipient periosteal bone healing only.(b)(6) 2019: compared to the previous x-rays no radiologically visible changes.No evidence of further bone healing, fracture lines are still well visible and unchanged periosteal callus formation.(b)(6) 2019: plate fracture and still clearly visible fracture lines.X-rays taken after the (b)(6) 2019 show the situation after fracture reduction and are therefore not relevant to the case.Patient data: (b)(6) female, born (b)(6) 1951, 170 cm, 100 kg, bmi 34.6, active lifestyle, retired the patient picked up the ncb plate that was removed during the surgery on (b)(6), 2019 herself from the hospital.Product evaluation: visual examination: the fractured ncb plate was returned for examination.No other components such as screws, cerclage wires or locking caps have been returned.The fracture of the plate runs through the central hole of the third three-hole pattern starting from proximal.Based on the x-rays taken (b)(6) 2019, the plate fracture is in the area of the femoral bone fracture.The distal fracture surface is highly polished, most likely due to post fracture contact between the distal and the proximal fracture parts; therefore, the characteristics of the original fracture surface are no longer visible.On the other hand, on the proximal fracture surfaces progression marks (beach marks) indicating a fatigue fracture with an origin at the screw hole chamfer of the non-bone facing surface can be seen.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.The plate shows scratches on both, the bone and the non-bone facing surface.See images attached.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination (except of the cerclage wire from depuy synthes) 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.Instruction for use (ifu), provided within the product packaging: instruction for use (ifu) for ncb® periprosthetic femur polyaxial locking plate system.Contraindications, page 3: all concomitant diseases that may impair the fixation of the implant and/or the success of the intervention.Lack of bone substance or poor bone quality which makes stable seating of the implant impossible.Warnings, page 3: the load-bearing capacity of the implant can be compromised by notching, scratching or striking the device.Precautions, page 4: these implants are designed for temporary usage and are generally removed once the bone can resume its normal function.The physician in charge is responsible for the decision to remove the implants.The risk of adverse effects such as secondary infections, allergies, material fatigue (breakage), implant failure and/or impaired blood circulation increases with the time the implant is implanted, delayed union, non-union, patient weight and activity level.Adverse effects, page 5: fatigue fracture bone fractures patient counseling information, page 6: complications and/or failure of prosthetic implants are more likely to occur in patients with unrealistic functional expectations, heavy patients, physically active patients, and/or with patients who fail to follow through with the required rehabilitation program.Physical activity can result in loosening, wear, and/or fracture of the implant.The patient must be instructed about all postoperative restrictions, particularly those related to occupational and sports activities and about the possibility that the implant or its components may wear out, fail or need to be replaced.Because prosthetic implants are not as strong, reliable, or durable as natural, healthy tissues/bones, all such devices may need to be replaced at some point.Conclusion: the provided medical records describe a left femur fracture of a female patient which was treated with a ncb plate on (b)(6), 2018.The implanted ncb plate fractured and the patient suffered a periosteosynthetic femur fracture, which was treated on (b)(6) 2019 (covered in (b)(4)).During this revision the complained ncb plate was implanted.The surgical report of this revision / implantation surgery was not provided.According to the provided post-treatment report the patient was able to steadily increase weight-bearing and mobility after the implantation until the patient was admitted to the emergency on (b)(6) 2019 with strong pain in the left thigh without any memorable trauma.The post-treatment report states a radiologically advancing callus formation, however fracture lines were clearly visible between the time of implantation on (b)(6), 2019 and the ncb plate fracture on (b)(6), 2019.The ct examination performed the day of admission describes the fracture of the ncb plate with periosteosynthetic femur fracture in the distal third of the femoral shaft with radiologically insufficient bony consolidation.The ncb plate was then revised on (b)(6), 2019.These findings can be confirmed with the analysis of the provided x-ray follow-up performed by a health care professional.The analysis describes the presence of periosteal callus formation with some fracture healing but still clearly visible fracture lines for the time between implantation and fracture of the ncb plate after 6 months in-vivo.Further, intraoperative findings of the revision surgery performed on (b)(6), 2019 revealed very little vitality of the femur near the fracture site and the presence of a crumbly mass, most likely bone cement from a previous surgery, which was removed.The defects were filled with callus and osteosynthesis was performed.The histological results describing abundant avital material and deposits of granular foreign material support the intraoperative findings.The visual examination of the complained product confirms the fracture of the ncb plate.The plate fracture is located in the area of the femoral bone fracture site.Even though the post-treatment report states that the patient could not remember any trauma, a possible traumatic cause is described in the preoperative surgical care document from the day of the surgery revision ((b)(6), 2019), since excoriations of the skin on the left body trunk are described.Based on the physicians letter the patient has an extensive medical history including, among others, permanent atrial fibrillation, osteoporosis, art.Hypertension, diabetes mellitus type ii, rheumatoid arthritis, hyperuricemia, lat.Hyperthyroidism, carcinoma (removed (b)(6) 2019), bilateral htep (1992/1997).According to the received patient data, the female patient was born 1951, has an active lifestyle and a bmi of 34.6 which falls within obesity class i.If and to what extend these factors might have contributed to the sequence of events leading to the fracture of the ncb plate remains unknown.As described in the applicable instruction for use (ifu), a lack of bone substance or poor bone quality that makes a proper seating impossible is a contraindication for these devices.In addition, the risk of adverse effects such as material fatigue fracture increases with the time the implant is implanted, delayed union, non-union, patient weight and activity level as these implants are designed for temporary usage only and may need to be replaced.The compatibility check showed that the ncb plate, all screws and the locking caps are zimmerbiomet products with approved product compatibility, the cerclage cable is a depuy synthes device.Further, the quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).In conclusion, the visual examination of the plate indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Based on the provided medical records it can be assumed that there was insufficient consolidation of the bone fracture after more than 6 months in-vivo which indicates a non-union.Together with the histological finding of abundant avital femoral bone and granular foreign material it is possible that there was poor bone quality at the fracture site.If and to what extent the aforementioned but also other comorbidities of the patient such as osteoporosis, diabetes, weight, lifestyle and compliance to rehabilitation protocols have influenced the fracture healing remains unknown.Additionally, based on the described preoperative excoriations of the skin on the left body trunk a fall of the patient cannot be excluded.Based on the investigation it can be assumed that the cause is multifactorial.Various patient and/or procedure related factors possibly contributed to a non-union leading to the fatigue fracture of the ncb plate; nevertheless, an exact root cause could not be found.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).
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