MAUDE Adverse Event Report: AESCULAP AG PLASMACUP SC SIZE 48MM; HIP ENDOPROSTHESES - ACETABULA

Model Number NH048T

Device Problem Scratched Material (3020)

Patient Problem Joint Dislocation (2374)

Event Date 04/27/2020

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 the plasmacup sc size 48mm.Specifically it was reported that a patient, who underwent total hip arthroplasty (tha) at this hospital in 1999, visited the hospital for dislocation.On (b)(6), a cup revision was performed.When doctor took a look at the excised implant, it seemed that the ceramic liner was partially damaged and the cup was partially scraped.The lot number is unknown due to the case before 2005.Possible cause: "probably implant failure due to recurrent dislocation".A revision surgery was necessary.Additional information was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00170_(b)(4)_nj103.

Event Description

Associated medwatch-reports: 9610612-2020-00170 (b)(4) nj103.

Manufacturer Narrative

Investigation results: due to a lack of components a investigation of the device was not possible.The lot numbers of all components are unknown, therefore a batch history review is not possible und must remain incomplete.The failure is most probably patient or usage related.A clear conclusion can not be drawn due to the lack of information.It is possible that the reported recurring dislocation reported by customer led to the adverse event.

• Brand Name: PLASMACUP SC SIZE 48MM
• Type of Device: HIP ENDOPROSTHESES - ACETABULA
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10071685
• MDR Text Key: 191530872
• Report Number: 9610612-2020-00169
• 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: 08/17/2020

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: NH048T
• Device Catalogue Number: NH048T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NJ103_BIOLOX PROST HEAD
• Patient Outcome(s): Required Intervention