MAUDE Adverse Event Report: IMPLANTCAST GMBH MUTARS®; MUTARS® CONNECTING PART 100MM INCL. SCREWS

Model Number 57300100

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

According to the incident description and the information received, it was not possible to exchange a mutars® connecting part with a new one.The new connecting part could not be fitted with the proximal femur / the stem.Therefore, an extension piece was implanted instead.No optical examination can be performed as neither the explants nor any pictures are available.The manufacturing documents and the material certificates of the mutars® connecting part were checked.These did not reveal any errors.The surgical technique and instructions for use were also checked and showed no deviations.Medical reports, such as surgery reports or pictures (intraoperative or x-ray) are not available.Instead of the affected connecting part, an extension piece was used to finish the revision.It is not known whether there were any health effects to the patient.The usage of an extension piece does not constitute an inferior treatment of the patient.Only in the case of a future revision, it could be more complicated to explant the extension piece than a connecting part.Due to the information at hand, no technical root cause could be determined as to why the connecting part did not fit.Since the extension piece was implanted without problems, a fault on the counterparts (proximal femur and the stem) is not assumed.For the error pattern "incompatibility" the calculated occurrence rate is 0.02% and therefore below the accepted value in the risk management of 3.0%.

Event Description

The following event was reported to implantcast gmbh: "we had a major problem the (b)(6) 2023.We shut changed a bonebridge too at proximal femur prosthesis and the verbindungsstück 100mm ref.(b)(4) were not convertible with the verbindungsstück 57300100 from our stock, as we thought it did.So we had to remove the bonebridge and implant a prox femur prosthesis.This was not good for the patient.[.]".

• Brand Name: MUTARS®
• Type of Device: MUTARS® CONNECTING PART 100MM INCL. SCREWS
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• MDR Report Key: 18138065
• MDR Text Key: 328123763
• Report Number: 3012523063-2023-00013
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K181778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57300100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1