MAUDE Adverse Event Report: AESCULAP AG PLASMACUP MSC SIZE 50MM; HIP ENDOPROSTHETICS

Model Number NH150T

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/11/2019

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 plasmacup msc.It was reported that in the in the periodic check-up on 2018 was no event in the x-ray and ct images.In (b)(6) 2019, the patient complained of feeling weak in the leg.He consulted the surgeon and x-ray images revealed apparent sign of osteolysis in the right proximal femur.In addition , what seemed like pseudo tumor is observed.These findings are indicative of pe insert wear.Revision surgery is scheduled in (b)(6) 2019.At the moment further information is not available about what is happening to the implants, until they are removed and visualized in the revision surgery.A revision surgery is necessary.An additional medical intervention was necessary.Additional information was requested.The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00814.9610612-2019-00815.9610612-2019-00816.9610612-2019-00817.

Manufacturer Narrative

D section: material information associated medwatch-reports: 9610612-2019-00814 9610612-2019-00815 9610612-2019-00816 9610612-2019-00817 investigation results: we did receive the products (pe-insert, metal stem, ceramic ball head) for investigation in contaminated condition.They were decontaminated according to internal standards.Primary surgery: (b)(6) 2005 revision surgery: (b)(6).2019 the products were investigated visually and microscopically.At the metal stem bony residues can be found on the outer surface of erratic appearance.Furthermore damages and scratches can be observed.These damages occurred most likely during the revision surgery.Secondary metal transfer can be found on the outer surface, on the chamfer and on the taper of the ceramic ball head.This metal transfer occurred most likely during or after the revision surgery.Primary metal transfer can be found inside the taper area.The pe-insert reveals a discoloration at the outer surface and imprints coming from the metal shell.It can not be decided whether the discoloration occurred in-situ or after the revision surgery, e.G.Due to the decontamination.Damages can be found on the front face and on the shoulder.It can not be decided clearly whether these damages occurred prior, during or after the revision surgery.On the inner surface of the insert, slight scratches/abrasion can be detected.Batch history review: the device history records have been checked for all 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 number of the pe-insert (51209325).Conclusion and root cause: the failure is most probably usage / patient related.Rational: based on the available information and after the investigation, we suspect that the failure is not product related.In general, the components are in an nearly expected condition after the implantation time.However, the scratches inside of the pe-insert are conspicuous but it can not be decided clearly how they occurred.It is possible that particles of unknown origin got into the bearing and were grinded between the ceramic ball head and the pe-insert.A correlation between the mentioned osteolysis and a pe-insert abrasion can not be evaluated on the basis of the available information.A capa is not necessary.

• Brand Name: PLASMACUP MSC SIZE 50MM
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9439321
• MDR Text Key: 170086313
• Report Number: 9610612-2019-00817
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K061699
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NH150T
• Device Catalogue Number: NH150T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention