MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS FEM.HEADS BIOLOX; HIP ENDOPROSTHESES - HEADS

Model Number AE-QAS-H547-01

Device Problems Fracture (1260); Migration (4003)

Patient Problems Joint Disorder (2373); Insufficient Information (4580)

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 a ceramic femoral head.According to the reporter there was a 15 year postoperative fracture of the ceramic ball head.A revision surgery was necessary.An additional medical intervention was necessary.Additional information was not provided nor available.Additional information has been requested but not yet received as to this day.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: due to the fact that only a small amount of fragments are available, an investigation could not take place.Batch history review: due to the fact that we did not receive a lot number and neither an article number, a review of the device history records must remain incomplete.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.Based upon the investigations results a capa is not necessary.

Event Description

The malfunction is filed under aag reference (b)(4)/ (b)(4).

• Brand Name: COLLECT.NO.QAS FEM.HEADS BIOLOX
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9785978
• MDR Text Key: 182305343
• Report Number: 9610612-2020-00038
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K060918
• 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: 04/23/2021

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: AE-QAS-H547-01
• Device Catalogue Number: AE-QAS-H547-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention