MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 12/14 22.2MM M; HIP ENDOPROSTHETICS

Model Number NK330K

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/17/2020

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.According to the complaint description the patient had after 24 years a post operative dislocation.The patient is an female and 75 years old.The initial surgery was on (b)(6) 1995.The patient had dislocation in the middle of work (farmer).X-ray examination revealed no problem to the implants.There might be a damage to the pe insert, which resulted in dislocation.The revision surgery is scheduled in (b)(6) to replace acetabular cup, insert and ball head.A revision surgery is necessary.Additional information was not provided nor available / was not available.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

General information: we received a complaint about a dislocation approx.24 years and 3 months postoperatively.We did not receive the components for investigation.Consequences for the patient: post-operative medical intervention was necessary -- revision surgery.Investigation: due to a lack of components, a failure description and investigation are not possible.No pictures available.Due to the fact that no lot number was provided, a review of the device history records must remain incomplete.Conclusion and root cause: the failure is most probably 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 etc.After the reported amount of implantation time (~ 24 years) we exclude a product related failure.It is possible that wear and tear in combination with bony changes led to the dislocation.However, this is only speculative.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 12/14 22.2MM M
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9819581
• MDR Text Key: 183100513
• Report Number: 9610612-2020-00055
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K040191
• 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: 05/28/2020

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: NK330K
• Device Catalogue Number: NK330K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR