MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS VEGA; KNEE ENDOPROSTHESES

Model Number AE-QAS-K521-56

Device Problem Device Fell (4014)

Patient Problem No Code Available (3191)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: no product was returned.Batch history review: a review of device quality and manufacturing history records are not possible because the lot number is unknown.Conclusion: not possible to determine an exact conclusion or root cause.Rationale: if further information or a product is returned, the investigation will be reopened.Safety case has been initiated, any action regarding capa will be addressed in safety case.When additional information is received a follow up report will be submitted.

Event Description

Per sus voluntary event mw5083248, received by fda, this is not an adverse event.Per the medwatch form, "atibial fixation failures on zone 5, 6 on stem, complete failure femur (fell off in wound) after incision was made." submitted via medwatch report.Little information known with no way to follow up.

Manufacturer Narrative

Investigation: no product at hand.Conclusion and root cause: based on the information available it is not possible to determine a possible root cause for the failure.Rationale: in light of the information received and due to the circumstance that we did not receive the complained devices it is not possible to determine a root cause for the mentioned failure.It is not possible to determine the failure itself.No capa is necessary.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8400611
• MDR Text Key: 138138338
• Report Number: 9610612-2019-00159
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-56
• Device Catalogue Number: AE-QAS-K521-56
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/27/2019
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other