MAUDE Adverse Event Report: AESCULAP AG E.MOTION PATELLA 3-PEGS P6 41X12MM; KNEE ENDOPROSTHESES

Model Number NO486

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.(b)(4).

Event Description

It was reported that there was an issue with no486 - e.Motion patella 3-pegs p6 41x12mm.According to the complaint description, a expired prothesis was implanted.There was no described patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

Manufacturer Narrative

Investigation: due to a lack of the product, an investigation could not take place.The implant mentioned above was provided to the customer by the loan service in france.Therefore, the investigation regarding the cause of the delivery, or presence of expired articles must be carried out by b.Braun france.A separate task with this information will be created.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available 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: due to the fact that this article was provided by the loan service france, a clear conclusion can not be drawn from our side.Based upon the investigations results there is capa is not necessary.

• Brand Name: E.MOTION PATELLA 3-PEGS P6 41X12MM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11050353
• MDR Text Key: 241253937
• Report Number: 9610612-2020-00930
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: NO486
• Device Catalogue Number: NO486
• Device Lot Number: 52193521
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/20/2021; 03/19/2021
• Supplement Dates FDA Received: 02/12/2021; 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1