MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 8/10 22.2MM M; HIP ENDOPROSTHESES - HEADS

Model Number NJ112K

Device Problem Material Integrity Problem (2978)

Patient Problem Joint Dislocation (2374)

Event Date 02/10/2020

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 isodur prosthesis head.12 years post-operative dislocation.The initial surgery was a total hip arthroplasty.In february, the patient fell backward and had dislocation.According to the patient, she was having snapping sensation in the prosthesis for a few days before the dislocation.Revision surgery was scheduled by the surgeon, however, at this point of time, has not been decided when.The surgeon stated that there is likely topical wear in the pe insert and it may have led the femoral head to dislocate from the insert.A revision surgery was necessary.Additional information has been requested.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

General information we received a complaint about a pe insert as well as a metal ball head regarding a dislocation postoperatively.We did not receive the complained components for investigation.Involved components: nj012t bicontact n plasmapore 8/10 size 12mm unknown.Ng952r plasmacup sc/msc trial cup size 52mm unknown.Consequences for the patient post-operative medical intervention was necessary à revision surgery.Batch history review due to the fact that a lot number was not provided, a review of the device history records must remain incomplete.Conclusion and root cause the failure is most probably usage/patient related.Rationale based on the information provided and without a product for investigation, a clear conclusion can not be drawn.A dislocation can occur due to several reasons e.G.: - implantation situation - patient behavior - bony changes / change of the position of the prosthesis after the primary surgery to date and on the basis of the statistical analysis, we exclude a product related failure.Corrective action according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: ISODUR PROSTHESIS HEAD 8/10 22.2MM M
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9819509
• MDR Text Key: 183005594
• Report Number: 9610612-2020-00054
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K042344
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NJ112K
• Device Catalogue Number: NJ112K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR