MAUDE Adverse Event Report: AESCULAP AG BIPOLAR CUP ID22.2MM OD47MM SELF-CENTER.; HIP ENDOPROSTHETICS

Model Number NK027K

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

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

Event Date 01/18/2024

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 product nk027k - bipolar cup id22.2mm od47mm self-center.According to the complaint description, the patient underwent a revision surgery on (b)(6) 2024 for an implant replacement due to recurrent dislocation.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Additional information was not provided nor available.Additional information regarding the patient is not available.The adverse event is filed under aesculap ag reference no.(b)(4).Associated medwatch-reports: 9610612-2024-00012 (internal aesculap ag ref.No.(b)(4) - nk330k - isodur prosthesis head 12/14 22.2mm m).(internal aesculap ag ref.No.(b)(4) - nk027k - bipolar cup id22.2mm od47mm self-center.) involved components: nk713t - bicontact sd plasmapore 12/14 size 13mm (internal aesculap ag ref.No.(b)(4).

• Brand Name: BIPOLAR CUP ID22.2MM OD47MM SELF-CENTER.
• 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: 18658757
• MDR Text Key: 334748818
• Report Number: 9610612-2024-00013
• Device Sequence Number: 1
• Product Code: KWY
• 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: 02/07/2024

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: NK027K
• Device Catalogue Number: NK027K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/07/2024
• 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: NK713T - LOT UNKNOWN
• Patient Outcome(s): Required Intervention