MAUDE Adverse Event Report: AESCULAP AG BIPOLAR CUP ID26MM OD53MM SELF-CENTERING; HIP ENDOPROSTHETICS

Model Number NK303K

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/11/2022

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 nk303k - bipolar cup id26mm od53mm self-centering.According to the complaint description, there was central migration of the implant.The initial surgery occurred on (b)(6) 2015 with artificial head insertion.The revision procedure was performed on (b)(6) 2022.An additional medical intervention was required.Additional patient information is not available.The adverse event /malfunction is filed under aag reference (b)(4).Involved components: 400562447 - nj122k- isodur prosthesis head 8/10 26mm m.

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: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

Event Description

Involved components.Nj122k - isodur prosthesis head 8/10 26 mm m - (400562447).

• Brand Name: BIPOLAR CUP ID26MM OD53MM SELF-CENTERING
• 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: 15175349
• MDR Text Key: 297338060
• Report Number: 9610612-2022-00209
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060707
• 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: 09/13/2022

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 Expiration Date: 11/21/2016
• Device Model Number: NK303K
• Device Catalogue Number: NK303K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2011
• 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: 400562447 - NJ122K- ISODUR PROSTHESIS HEAD 8/10 26; NJ122K - ISODUR PROSTHESIS HEAD 8/10 26 MM M
• Patient Outcome(s): Required Intervention
• Patient Sex: Male