MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 12/14 36MM XXL; HIP ENDOPROSTHESES - HEADS

Model Number NK673K

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Death (1802); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Type  Death  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K082991.When additional information is received a follow up report will be submitted.

Event Description

It was reported one year 4 months post operative death due to metallosis.The reporter indicated the patient was active and born in (b)(6).On (b)(6) 2010 a biocontact stem (size 10) and a plasmacup (size 52) and ceramic cup and ceramic head (size 32 were implanted.On (b)(6) 2017 it was reported there was a break in the ceramic head with extensive metallosis (fragments of the ceramic).Lab results and x-rays were not provided.Results regarding confirmation of the metallosis have been requested.No other information has been received regarding intervention or revision.The reporter indicated the last intervention on (b)(6) 2017, acetabular system shoulder 54, with metal head with neck size 36.(clarification has been requested regarding this intervention).Per the reporter, four months ago the patient began with blindness, loss of muscle mass and pseudo-tumors due to the extensive metallosis due to the friction of the metallic head with ceramic particles.Recent notification that the patient expired was received.Additional information has been requested, however, no yet received.Associated medwatches: 9610612-2019-00286; 9610612-2019-00287; 9610612-2019-00288; 9610612-2019-00289; 9610612-2019-00291; 9610612-2019-00292.

Manufacturer Narrative

Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: e2014018 investigation: we did not receive the products for investigation.No product at hand, therefore a failure description is not possible.On the provided pictures by the hospital, a clearly abraded metal ball head can be seen.Furthermore on the inner surface of the pe-insert black residues can be found.These residues are most likely small ceramic fragments.No product at hand, therefore an investigation is not possible.Batch history review: the lot numbers have been checked and found to be according to specification valid during the time of production.There are no further complains registered again any of these lot numbers.The lot number of the metal ball head is not available to date.Conclusion and root cause: the failure is most probably usage related.Rationale: we did not receive the products for an investigation.However, on the basis of the available information and picture it is possible to evaluate this case.After the breakage of the ceramic ball head in the year 2017, the above mentioned metal ball head as well as a pe-insert have been implanted.According to our ifu and common knowledge, it is not allowed to implant such combination after a ceramic fracture due to the risk of three-body wear.Due to three-body wear it is possible that a metal ball head abrades itself at ceramic fragments which get into the bearing after a ceramic fracture.This can finally lead to metallosis.Excerpt of ifu: warning risk of wear and tear due to ceramic fragments inside the joint following revision surgery that involved breaking ceramic components! - do not implant a metal head (risk of three-body wear).No capa necessary.Associated medwatch: 9610612-2019-00286, 9610612-2019-00287, 9610612-2019-00288, 9610612-2019-00289, 9610612-2019-00290 (this report), 9610612-2019-00291, 9610612-2019-00292.

• Brand Name: ISODUR PROSTHESIS HEAD 12/14 36MM XXL
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8576276
• MDR Text Key: 143929877
• Report Number: 9610612-2019-00290
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK673K
• Device Catalogue Number: NK673K
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/06/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other