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Medical product: unicortical screw 5.0 mm diameter 16 mm length warning: this device is not approved for screw attachment or fixation catalog#: 02.02151.016; lot#: unknown.Cerclage cable with crimp 1.8 mm diameter cable 36 inch (910 mm) length catalog#: 00-2232-002-28; lot#: unknown.Ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive catalog#: 47-2232-060-01; lot#: unknown.Ncb, locking cap catalog#: 02.02150.300; lot#: unknown.Unicortical screw 5.0 mm diameter 12 mm length warning: this device is not approved for screw attachment or fixation catalog#: 02.02151.012; lot#: unknown.Ncb, cortical screw, 5.0 mm, 34 mm catalog#: 02.02150.034; lot#: unknown.Ncb, cortical screw, 5.0 mm, 36 mm catalog#: 02.02150.036; lot#: unknown.Ncb, cortical screw, 5.0 mm, 38 mm catalog#: 02.02150.038; lot#: unknown.Ncb, cortical screw, 5.0 mm, 40 mm catalog#: 02.02150.040; lot#: unknown.Therapy date: unknown.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer gmbh winterthur legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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).Product not available.
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Investigation results were made available.Investigation and conclusion 1.Event description: it was reported that the patient was implanted with a periprosthetic femur plate on (b)(6), 2019, which required revision on (b)(6), 2019, due to plate fracture.Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.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.- review of received data: please note that the documents mentioned below have been translated from italian into english and summarized.Due to poor image resolution and handwriting, not all text could be deciphered.- record from u.O.C di ortopedia e traumatologia monopoli: declaration of informed consent for surgical intervention for periprosthetic right femur fracture.Signed by patient (b)(6) on (b)(6) 2019.- record from (b)(6), dated (b)(6) 2019: we inform you that the patient (b)(6) was medically treated today for osteosynthesis of right periprosthetic femur fracture.- surgical record from (b)(6) from (b)(6) 2019: diagnosis: periprosthetic right femur fracture.Please note that the description of the procedure could not be deciphered due to the handwriting.- letter from dr.(b)(6), dated (b)(6), 2021: medico-legal observations related to (b)(6), 78 years old.As a consultant of the party, i have read the technical report of (b)(6), and before going into the details of our observations, it is necessary to summarize the radiographic examinations.The patient already had a total hip prosthesis on the right side.After an accident, the patient suffered a spiroid fracture of the femur just below the prosthetic stem with a medially displaced third fragment.For this reason, the patient was transferred to the operating room of (b)(6), where the patient underwent osteosynthesis with a plate, screws, and two proximal cerclage wires on (b)(6) 2019.Without any trauma, a new fracture of the same segment occurred post-surgery.The patient was then hospitalized at the orthopedic clinic of the (b)(6), where the old prosthesis and the broken plate were removed and a new prosthesis with a stem extended to the distal diaphyseal third of the femur and a new plate and screws were implanted.In this case, we are dealing with a spiroid fracture in which a third fragment displaced medially, which was not perfectly aligned along the loading matrices during synthesis, a situation that over time has led to an abnormal distribution of the load beyond the limits of elasticity of the synthesis medium, resulting in bone refracture.However, it is certain that the immediate explantation of the old prosthesis and the implantation of a new prosthesis with a longer stem, together with the plate and cerclage wires, would have allowed greater stability of the fracture and avoided another hospitalization, anesthesia, and surgery.Important note from the author of the legal manufacturer: please note that on the documents received, the above-mentioned figures are of such poor quality that the events described cannot be recognized.- letter from prof.(b)(6), signed on (b)(6) 2021: (b)(6), appointed expert, declares that on (b)(6) 2021 he received from dr.(b)(6) the prosthetic parts seized on (b)(6) 2019 at the (b)(6) orthopedics of the (b)(6)and entrusted to him in judicial custody.- investigation report by prof.(b)(6) (summary): the undersigned reminds that the question he has to answer concerns the ascertainment of eventual defects of realization on the prosthesis and the identification of the causes of its breakage.He then proceeds to share photograph number 1 showing all 16 prosthetic parts.The detail on which attention is drawn is a periprosthetic plate fractured in two parts.Following, the consultants are informed that the material making up the plate is probably a medical titanium alloy, a fact confirmed by prof.(b)(6).The microscopic analysis of the fracture surface clearly shows a fracture due to bending fatigue of the plate and that fracture due to overload is excluded.In other words, the fracture of the plate occurred as a result of the application of a very high number (in the order of hundreds of thousands) of stress cycles and not due to a single high overload, such as that which could occur during a fall.Photographs number 3 and 4 show the trigger points of the fractures and the signs of their progress until the final break.The undersigned affirms that in the case of a lack of fracture healing the plate is more stressed in bending and this may be the cause of the fracture.Prof.(b)(6) agrees with what has been said by the expert and believes that the experimental tests are sufficient.Dr.(b)(6) communicates that prof.(b)(6), during the operation of removal of the fractured plate had highlighted the presence of pseudo-arthrosis, that is the lack of healing of the fracture.3.Product evaluation: - no product was returned; therefore, visual evaluation could not be performed.However, images of the complained ncb periprosthetic femur plate can be found in the investigation report of prof.(b)(6).Based on the images, the fracture of the ncb plate running through the sixth screw hole from distal can be confirmed.The progression marks seen on the images of the fracture surfaces point to a fatigue fracture.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: review of the manufacturing and material records could not be performed due to missing lot number.5.Conclusion: the patient underwent right total hip arthroplasty on an unknown date.After an accident, the patient suffered a spiroid fracture of the femur just below the prosthetic stem with a medially displaced third fragment.Subsequently, the patient underwent osteosynthesis with a ncb periprosthetic femur plate, screws and cerclage wires on (b)(6) 2019.Without any trauma, a new fracture of the same segment occurred post-surgery requiring revision of the prosthetic stem and the osteosynthesis on (b)(6) 2019.The third party experts (prof.(b)(6) and dr.(b)(6) describe a spiroid femur fracture in which a third fragment that displaced medially was not perfectly aligned along the loading matrices during synthesis resulting in an abnormal distribution of the load beyond the limits of elasticity of the synthesis medium and resulting in fatigue fracture of the plate and bone refracture.Further, according to prof.(b)(6) the presence of pseudo-arthrosis, that indicates the lack of fracture healing, was seen during the revision surgery.Based on the investigation the reported fracture of the ncb plate can be confirmed.The most likely cause is a non-union of the periprosthetic femur fracture, leading to a fatigue fracture of the ncb plate.It cannot be excluded that other patient- and/or procedure-related factors may have contributed to the fracture, which is why no definite cause could be determined.The investigation did not identify a nonconformance 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).
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