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

Model Number NH150T

Device Problem Fracture (1260)

Patient Problem Joint Disorder (2373)

Event Date 03/09/2020

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.According to the complaint description it was reported that the ceramic insert fractured 9 years post surgery.A revision surgery was necessary.The patient had heard an unusual noise from the prosthesis.An x-ray result had revealed the breakage.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00142 ((b)(4) - nj106), ((b)(4) - nh150t).Involved components - nh102 - sc/msc ceramics insert 32mm 48/50 sym.51723967 (not sold to us).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00142 ((b)(4)- nj106); 9610612-2020-00141 ((b)(4)- nh150t).General information: we received a complaint about a nh102 - sc/msc ceramics insert 32mm 48/50 sym regarding a postoperative breakage.Consequences for the patient: post-operative medical interventions was necessary (revision surgery).Investigation: no investigation possible due to a lack of components.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.Two similar complaints registered against the same lot number of the ceramic insert (51723967).Conclusion and root cause: the failure is most probably usage/patient related.Rationale: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Based on our experience, we suspect that failure is usage (e.G.Due to an improper implantation situation) or patient (e.G.Due to overload) related.Corrective action according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.The failure rate is outside the risk analysis.Due to the fact that the product is not on the market anymore since 03/2013, an adjustment has not to be made.

• Brand Name: PLASMACUP MSC SIZE 50MM
• Type of Device: IMPLANTS PLASMACUP
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9968417
• MDR Text Key: 188807670
• Report Number: 9610612-2020-00141
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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 Expiration Date: 10/01/2020
• Device Model Number: NH150T
• Device Catalogue Number: NH150T
• Device Lot Number: 51701607
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NH102 - 51723967.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR