MAUDE Adverse Event Report: AESCULAP AG METHA SHORT HIP STEM CAP SIZE 2; HIP ENDOPROSTHETICS

Model Number NC082T

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with metha hip stem.On (b)(6) 2009 the patient was advised to receive a surgery to treat the left hip coxarthrosis.On (b)(6) 2010 the same was advised for the right hip.Following both surgeries the patient suffered from unspecified "severe and permanent consequences", due to metallosis caused by the defective prosthesis.The patient was treated by a physician and revision(s) were performed.A revision surgery was necessary.Information about the involved products has been received, related to b)(4).The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2020-00080 - this report.9610612-2020-00081 ((b)(4) nc088k).9610612-2020-00082 ((b)(4) nc082t).Same patient- involved component (b)(4) nc088k-51555649.(9610612-2019-00781).

Manufacturer Narrative

Associated medwatches: 400450880 - nc088k - 51555649 400466520 - nc082t- 51540632 400466521 - nc088k - 51623012 400466522 - nc082t - 51586516 investigation results: right hip: nc088k - metha neck 12/14 135°/0° - batch: 51623012 - device manufacturing date: 12 february 2010 nc082t - metha short hip stem cap size 2 - batch: 51586516 - device manufacturing date: 21 october 2009 left hip: nc088k - metha neck 12/14 135°/0° - batch: 51555649 - device manufacturing date: 09 april 2009 nc082t - metha short hip stem cap size 2 - batch: 51540632 - device manufacturing date: 20 march 2009 we did not receive the prothesis for an investigation.It remained unclear if one or both prothesis have been explanted.On the basis of the provided information, both aesculap prothesis have been combined with components from competitors.Investigation: no product at hand, therefore a failure description is not possible.Batch history review: the device history records have been checked for the available lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot numbers.Conclusion and root cause: based on the information available, the root cause is most probably usage related.Rationale: due to the fact that we did not receive sufficient information regarding the product nor the product itself for investigation, the root cause analysis must remain incomplete.Based on our experience, micro movements between the neck adapter and the metal stem could facilitate an iron contribution.Micro movements can be triggered due to tissue residues within the cone/stem connection intraoperatively.The surgeon have to ensure that the cone is clean and rinsed.Furthermore an overload situation after the surgery can also lead to micro movements and therefore to an ion contribution.Additionally, based on the provided information, aesculap products were mixed with competitor products.Such combinations are not tested by aesculap and should be avoided however, we have not enough information to fully evaluate this case, e.G.We do not know if the patient have another prosthesis etc.If we receive more information or the product, this case will be re-evaluated.

• Brand Name: METHA SHORT HIP STEM CAP SIZE 2
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9849315
• MDR Text Key: 184318987
• Report Number: 9610612-2020-00080
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K071916
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: NC082T
• Device Catalogue Number: NC082T
• Device Lot Number: 51540632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NC088K - 51555649
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR