MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, B/3, TAPER 12/14; FITMORE HIP STEM

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Off-Label Use (1494)

Patient Problems Bone Fracture(s) (1870); Metal Related Pathology (4530)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) 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 for review.The manufacturer received surgical reports and a letter from legal and they will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during 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

It was reported that a revision surgery was performed due to fracture of the femur following the revision, blood test revealed elevated levels of ions.

Event Description

Correction of the event: it was reported that the patient was implanted a bilateral thp.Seven years later, the patient fell from a bicycle, that had caused the fracture of the left femur.The patient underwent a total revision of the left hip, following the revision of the prosthesis, blood tests revealed elevated levels of ions.Two complaints were opened, as left and right hip products are involved: (b)(4) (present complaint) treats the patient's right hip; elevated ion levels.(b)(4), mfr 0009613350-2021-00588, treats the patient's left hip; bicycle fall which fractured femur with subsequent elevated ion levels.

Manufacturer Narrative

Investigation results were made available.Review of event description: the patient underwent primary bilateral hip replacement on (b)(6) 2009.A metal-on-metal lima cup and head, an adapter, and a zimmer fitmore stem were implanted in both hips.On (b)(6) 2016, a fall with the bicycle had caused a fracture of the left femur.Subsequently, the patient underwent revision of the left hip prosthesis.Further, it was reported that after this revision, blood tests revealed elevated ion levels, which led to a revision of the right hip prosthesis on (b)(6) 2018.Please note, that the revision of the left hip is covered in (b)(4).Review of received data: please note that the provided documents have been translated from italian into english and the content relevant to the elevated ion levels and the additional procedure of the right hip has been summarized below.Letter from dr.(b)(6) (pesaro, (b)(6) 2021) the patient, suffering from bilateral coxarthrosis despite her young age, decided to undergo bilateral hip replacement surgery in a single session.The surgery was performed at (b)(6) on (b)(6) 2009.A lima cup 48 mm was placed with a 42 mm metal insert.A prosthesis of the same size was subsequently placed in the left hip.From the operating report it is noted that the intervention was performed without any problem and was perfectly successful both on the right and on the left.After clinical and radiological controls, which showed good positioning of both prostheses, the patient resumed normal activity.The patient did not report any particular problems, until the patient suffered a periprosthetic fracture of the left femur during an accident with the bicycle on (b)(6) 2016.The patient was treated for prosthetic replacement and periprosthetic fracture.The surgical report mentions a hypotrophic gluteus medius, the presence of metallic infiltrate and bone resorption at the greater trochanter and around the femoral stem.Some areas of the acetabulum show bony necrosis, presence of bony defects on the anterior and superior wall.Cultures were taken intraoperatively.The postoperative diagnosis is peritrochanteric fracture of the left htep with metallosis.The culture examination of the periprosthetic material was negative, pointing to an advanced form of metallosis.The patient had high values for chromium and cobalt even before the fracture.In 2017 and early 2018, the patient began to experience not only pain, but also episodes of joint noise in the remaining right prosthesis.The patient was again admitted to the clinic humanitas for revision of the right hip prosthesis on (b)(6) 2018.The surgical report mentions a hypotrophic gluteus medius with metallotic tissue.The stem is integrated and left in situ.The head and metal cup with insert are removed.Some areas of the acetabulum show bony necrosis and bony defects.The iliopsoas muscle appears infilled with metal debris and there is a pseudotumor-like collection in the bursa.Postoperative diagnosis is right tha with metallosis and ion elevation.Therefore, it was the choice of the type of prosthesis (metal-on-metal) that led to the failure of the two prosthetic procedures over time.Discharge letter from (b)(6) (pesaro, (b)(6) 2016) the patient is discharged with the following diagnosis: periprosthetic fracture of the left femur.The patient was admitted to our department on (b)(6) 2016 and, after clinical and instrumental investigations, was given indication of surgical revision of the prosthetic implant and osteosynthesis.The patient decided to continue treatment at another site.Surgical report from (b)(6) 2009: the surgery was performed without complications.Product evaluation: the fitmore stem removed from the left hip in 2016 was not returned and the fitmore stem implanted in the right hip remains implanted; therefore, no product evaluation could be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the listed product combination, consisting of the zimmer fitmore stem and the adapter, head and acetabular cup from lima lto s.P.A., has not been approved/tested for use and is therefore considered off-label use [1].Dhr review: no deviations and/or anomalies were discovered during review of the device manufacturing records of the fitmore stem with ref# 01.00551.203, lot# 2476244, that may have affected the surgical outcome or contributed to the reported event.Therefore, it is not expected that the manufacturing process contributed to the reported issue.Instruction for use (ifu) for fitmore hip stems: this leaflet was delivered together with the fitmore stems ref# 01.00551.203, lot# 2476244 and ref# 01.00551.202, lot# 2476242 [1]: important information for the operating surgeon: only authorized combinations must be used.To determine whether these devices have been authorized for use in a proposed combination, please contact your zimmer sales representative or visit the zimmer website: www.Productcompatibility.Zimmer.Com.Femoral stems for total hip arthroplasty: fitmore hip stem: these 12/14 stems may be used with zimmer ceramic femoral heads (6418 and 6428 series), biolox® forte ceramic heads (12.28.05/07; 12.32.05/07), cerasul® ceramic femoral heads for ceramic-on-ceramic (407.0101/03), sulox¿ ceramic heads (17.28.05/07; 17.32.05/07), biolox delta ceramic femoral heads (8775 series) and biolox option ceramic femoral head systems (8777 series).Warnings: implants and implant parts must only be combined with components belonging to the same system.No liability is accepted for products of third parties that are used by the purchaser or user.Do not use this product for other than labeled indications (off-label use).Adverse effects: wear, metal sensitivity, corrosion of metal implants, pelvic, femoral, or acetabular fractures.Conclusion: the patient underwent primary bilateral hip replacement on (b)(6) 2009.A metal-on-metal lima cup and head, an adapter, and a zimmer fitmore stem were implanted in both hips.On (b)(6) 2016, a fall with the bicycle had caused a fracture of the left femur.As a result, the patient underwent revision of the left hip prosthesis.Further, it was reported that after this revision, blood tests revealed elevated ion levels, which led to a revision of the right hip prosthesis on (b)(6) 2018.The manufacturing records of the fitmore stem show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).According to the instruction leaflet of the fitmore hip stem, that was provided together with the complained stems in 2009, the fitmore stems must only be combined with zimmer femoral heads [1].No liability is accepted for products of third parties that are used by the purchaser or user.Based on the copy of the product stickers, it is obvious that the zimmer fitmore stems were combined with acetabular cups, femoral heads and adapters manufactured by lima lto s.P.A.This product combination has not been approved/tested for use and is therefore considered off-label use.Furthermore, the elevated levels of cobalt and chromium ions mentioned in dr.(b)(6) letter should be originated from the metal-on-metal bearings manufactured by lima lto s.P.A.Since they were made of a cobalt-chromium-molybdenum alloy.The fitmore stem, on the other hand, is made of a titanium alloy not containing any cobalt, any chromium or molybdenum.The fitmore stem of the left htep, which was reported to have been removed in 2016, was not made available for examination, and the fitmore stem of the right htep remains implanted.Therefore, neither fitmore stems were available for examination.According to the surgical report of the implantation performed on (b)(6) 2009, the bilateral hip replacement was performed without complications.Furthermore, based on the discharge letter of the (b)(6) dated (b)(6) 2016, the periprosthetic femur fracture of the left side can be confirmed.The most likely cause is the bicycle accident.It remains unknown if other factors contributed to this event.On the other hand, the metal-related pathology, consisting of metallosis, high ion levels and bony defects as reported in dr.(b)(6) letter, cannot be confirmed due to the lack of medical records such as revision and laboratory reports and due to the unavailability of the fitmore stems.It remains unknown if and to what extent there was a metal-related pathology, if and to what extent the product combination contributed to it, and if and to what extent the fitmore stems contributed to it, as one fitmore stem was removed due to the periprosthetic fracture and the other was left in situ.References: [1] zimmer gmbh (2007).Fitmore hip stem.D011500240 ed.08/07.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).

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, B/3, TAPER 12/14
• Type of Device: FITMORE HIP STEM
• 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: 12842103
• MDR Text Key: 281023301
• Report Number: 0009613350-2021-00587
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024591578
• UDI-Public: 00889024591578
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K192236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.203
• Device Lot Number: 2476244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female