MAUDE Adverse Event Report: AESCULAP AG PLASMACUP SC SIZE 52MM; HIP ENDOPROSTHETICS

Model Number NH052T

Device Problem Expulsion (2933)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

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 nh052t - plasmacup sc size 52mm.According to the complaint description, the patient had recurrent dislocations.The initial total hip arthroplasty (tha) had been performed ten (10) years ago.A revision was planned for (b)(6) 2022.The cup was to be replaced due to luxation; the surgeon was also considering a 32mm head.Additional information was requested.The adverse event / malfunction is filed under aag reference 400567883/100031444.Involved components: nj103 biolox prosthesis head 8/10 28mm l (400567884), nh473 sc/msc pe-insert 28mm 52/54 asym.(400567885), nj214t bicontact d plasmapore 8/10 size 14mm (400567886).

Manufacturer Narrative

Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion/measures: based upon the investigation results a clear root cause cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.If the device is returned in the future, an investigation will again be completed at that time.Based upon the investigation results, a capa is not necessary.

Event Description

Involved components: nj103 biolox prosthesis head 8/10 28mm l (400567884).Nh473 sc/msc pe-insert 28mm 52/54 asym.(400567885).Nj214t bicontact d plasmapore 8/10 size 14mm (400567886).

• Brand Name: PLASMACUP SC SIZE 52MM
• 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: 15441891
• MDR Text Key: 300118254
• Report Number: 9610612-2022-00274
• 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,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NH052T
• Device Catalogue Number: NH052T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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: NH473 SC/MSC PE-INSERT 28MM 52/54 ASYM; NH473 SC/MSC PE-INSERT 28MM 52/54 ASYM.; NJ103 BIOLOX PROSTHESIS HEAD 8/10 28MM L; NJ103 BIOLOX PROSTHESIS HEAD 8/10 28MM L; NJ214T BICONTACT D PLASMAPORE 8/10 SIZE 14MM; NJ214T BICONTACT D PLASMAPORE 8/10 SIZE 14MM
• Patient Outcome(s): Required Intervention