MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIAL COMP.OFFSET CEMENTED T1; KNEE ENDOPROSTHETICS

Model Number NB011Z

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Swelling (2091)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product at hand, therefore a failure description is not possible.Due to the circumstance that it is unknown which of the mentioned components could be responsible for the mentioned suspicion of metallosis all components were created as leading material.This case was discussed with a specialist from the product management.Without the explanted devices it is not possible to determine the root cause for the mentioned suspicion of metallosis.There are no information how significant the metal debris (metallosis) in the patient exist.Furthermore a metallosis within 16 days postoperative is very unusual.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause.Based on the information available it is not possible to determine a possible root cause for the failure.At that time we assume that the failure is not product related.Rationale: due to the circumstances that we did not receive any devices for investigation it is not possible to determine a conclusion and root cause.There are no hints for a material problem.According to the quality standard and dhr files a material defect and production error can be excluded.

Event Description

It was reported suspicion of metallosis 16 days post-operatively.Per the reporter: metallosis prosthetic joint in absence of microscopic ruptures in the prosthetic implant with the limits related to the intraoperatory valuation.Clarification has been requested on the above statement.It was also reported per the doctors, the patient started with localized pain and swelling of the knee.It is unknown if blood test for the metallosis diagnosis are available.An enduro prosthesis was used as a revision of a precedent prosthesis (date and manufacturer of precedent prosthesis is unknown).After having removed the enduro prosthesis, a cement spacer was inserted.Per the reporter, the patient will probably be admitted for a new prosthesis intervention when the blood values are within normal range.The patient also has a prosthesis in the other knee (unknown type or when this was implanted).Additional information has been requested, however, not yet received.All med watch submissions related to this are: 9610612-2019-00238, 9610612-2019-00226, 9610612-2019-00227, 9610612-2019-00228, 9610612-2019-00229, 9610612-2019-00230, 9610612-2019-00231, 9610612-2019-00232, 9610612-2019-00233, 9610612-2019-00234, 9610612-2019-00235 (this report).

• Brand Name: AS ENDURO TIBIAL COMP.OFFSET CEMENTED T1
• Type of Device: KNEE 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8501783
• MDR Text Key: 141573161
• Report Number: 9610612-2019-00235
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: NB011Z
• Device Catalogue Number: NB011Z
• Device Lot Number: 52291748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2019
• Device Age: 27 MO
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR