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

Model Number NH050T

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2022

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 nh050t - plasmacup sc size 50mm.According to the complaint description, the product broke during surgery.In the x-ray image, the anteversion of the cup was not seen, and it was rather backward.The dislocation resistance was improved by changing the head size from m to xl.A revision surgery was necessary.The initial procedure had been total hip arthroplasty (tha); and it was noted that the patient experienced dislocation many times.The adverse event is filed under aag reference: (b)(4).Involved components nj211t - bicontact d plasmapore 8/10 size 11mm - lot: 51664088, nj107 - biolox prosthesis head 8/10 32mm m - lot: 51705304, nh102 - sc/msc ceramics insert 32mm 48 - 51708119.

• Brand Name: PLASMACUP SC SIZE 50MM
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15979540
• MDR Text Key: 305464344
• Report Number: 9610612-2022-00373
• Device Sequence Number: 1
• Product Code: PLW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NH050T
• Device Catalogue Number: NH050T
• Device Lot Number: 51676348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NH102 - LOT 51708119; NJ107 - LOT 51705304; NJ211T - LOT 51664088
• Patient Outcome(s): Required Intervention