MAUDE Adverse Event Report: IMPLANTCAST GMBH ECOFIT; ECOFIT® HIP STEM COXA VARA CEMENTLESS STANDARD SZ. 8,75MM CPTI

Model Number 30388087

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

Damage analysis: optical inspection: an optical inspection of the affected medical device could not be performed.So far, the device is not available for inspection.Assessment of the manufacturing protocols: the manufacturing protocol of the medical devices known were checked.These show no deviations.Assessment of the dimensional accuracy of the construction as no product is available for inspection, an assessment of the dimensional accuracy cannot be performed.Functional testing: as no product is available for inspection, a functional testing cannot be performed.Assessment of the mechanical properties: the approval of the basic materials was performed.External evaluation: as no explant is available for inspection, an external evaluation cannot be commissioned.Assessment of the medical records: patient gender: female.Age at time of event: (b)(6) years.Weight: (b)(6) kg.Height: 160 cm.Degree of activity: low.Past medical history: implantation date: (b)(6) 2020 (diagnosis: coxarthrosis left).Explantation date: (b)(6) 2020 (diagnosis: periprosthetic fracture, type vancouver (b)(4)).Several x-rays are available for inspection.The x-rays do not show any hint for the cause.Surgical technique and instructions for use: the surgical technique 'ecofit® hip stem 133°_123° st' describes the complete implantation process in detail.There are no indications of an incorrect or incomplete surgical technique.The instruction for use (ifu) 'cementless femoral hip stems' was checked.There is no indication of incorrect instructions for use.Summary: the medical device is not available for inspection at the moment.The manufacturing protocols of the affected products were checked.These show no deviations.Several x-rays are available for inspection.The x-rays do not show any hint for the cause.

Event Description

Postoperative with second mobilization under full load periprosthetic femoral shaft fraction (type vancoover (b)(4)) without trauma on the left.No osteoporosis known.

Manufacturer Narrative

Damage analysis.1 visual inspection (condition of the product).The affected product is not available.Since no corresponding image material is available either, no visual inspection of the concerned product could be carried out.2 assessment of the manufacturing protocols.The manufacturing documents and the test records were checked.There were no deviations during the production process, the products have been released with the final inspection.3 assessment of the dimensional accuracy of the construction it was not possible to check the dimensional accuracy of the concerned product, as it is not available.4 functional testing without the affected product no functional test could be performed.The components used are compatible with each other under consideration of ref and lot.5 assessment of the mechanical properties for the raw material used, materials were released in accordance with the procedure instruction "va_743-mat_freigabe von werkstoffe".According to the documents available, the materials used corresponded to the specification.6 external evaluation.An external evaluation could not be commisioned without the concerned product.7 assessment of the medical records general information about the affected patient.- patient gender: female.- age of time of event: 85 years.- height: 160cm.- weight: 80kg.- degree of activity: less.- date of implantation: (b)(6) 2020.- date of incident: (b)(6) 2020.- date of explantation: 07.06.2020 (b)(6) 2020.Several x-rays are available as well as the surgical reports on implantation and revision.However, no indications of the cause could be determined from these documents.8 surgical technique and instructions for use the surgical technique "ecofit® hip stem system 133°/123°" describes the complete implantation process in detail.There are no indications of an incorrect or incomplete surgical technique.The instruction for use (ifu) "cementless femoral hip stems" was checked.There is no indication of incorrect instructions for use.In section 12 "complications", the periprosthetic fracture is indicated as follows: in the following the most frequent side effects and complications are listed, which can occur in connection with a hip endoprosthesis implantation: periprosthetic fractures.Bone fractures can occur intraoperatively and as a consequence of an implant loosening or due to overload as well as one-sided joint load.Summary - categorization and interpretation of the results.The concerned product is not available.Since no corresponding image material is available either, no optical assessment of the concerned product could be carried out.No indications of the cause could be determined from the medical documents.The manufacturing documents do not contain any deviations during the manufacturing process.No technical cause could be determined on the basis of the available data.

Event Description

Postoperative with second mobilization under full load periprosthetic femoral shaft fraction (type vancouver ag and al) without trauma on the left.No osteoporosis known.

• Brand Name: ECOFIT
• Type of Device: ECOFIT® HIP STEM COXA VARA CEMENTLESS STANDARD SZ. 8,75MM CPTI
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• MDR Report Key: 10229050
• MDR Text Key: 199723187
• Report Number: 3012523063-2020-00007
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K163577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 30388087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECOFIT® CUP EPORE® CEMENTLESS Ø 48MM; ECOFIT® CUP EPORE® CEMENTLESS Ø 48MM; IC-HEAD BIOLOX® DELTA TAPER 12/14MM Ø 28MM, M; IC-HEAD BIOLOX® DELTA TAPER 12/14MM Ø 28MM, M
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 80