MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLLECT.NO.QAS HIP STEMS METHA; MPLANTS METHA

Model Number AE-QAS-H546-32

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that there is a possible metallosis in patient.All med watch submissions related to this report are: 9610612-2018-00319, 9610612-2018-00320.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: based on the information available, the root cause is most probably usage related.Rational: according to the provided information it came to mix and match during the primary surgery.Aesculap components were combined with competitor components.This is not allowed according to our ifu.The combination between the competitor ball head with the metha neck adapter may have led to a high leverage effect.This combination is not tested and approved by aesculap.A high leverage effect can contribute to a higher ion release.There are no indication of a product or material deviation.No capa is necessary.

• Brand Name: COLLECT.NO.QAS HIP STEMS METHA
• Type of Device: MPLANTS METHA
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7685216
• MDR Text Key: 114286551
• Report Number: 9610612-2018-00320
• Device Sequence Number: 1
• Product Code: KXD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-H546-32
• Device Catalogue Number: AE-QAS-H546-32
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/03/2018
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other