MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D15X52MM CEMENTED; KNEE ENDOPROSTHETICS

Model Number NR192Z

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

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 as tibia offset stem.The patient was initially implanted with enduro components on (b)(6) 2019.All components were cemented one-on-one with tobramycin placement of stimulan pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.The pre-operative diagnosis in 2020 was multi-directional instability following the primary left total knee.There later was a failed left total knee and revision on (b)(6) 2020, and there had been increased pain noted prior to surgery.During the procedure, black debris was found from the carbon fiber slip.A revision surgery was necessary.The implants that were revised were the aesculap enduro components.A competitor's products were used instead.Additional information was requested.The adverse event is filed under xc (b)(4).Associated medwatches 9610612-2020-00104 ((b)(4) nb014z), 9610612-2020-00124 ((b)(4) nr291z), 9610612-2020-00125 ((b)(4) nr400z), 9610612-2020-00126 ((b)(4) nr870z), 9610612-2020-00127 ((b)(4) nr191z).

Manufacturer Narrative

Associated medwatches: 9610612-2020-00104 (400468335 nb014z); 9610612-2020-00124 (400468805 nr291z); 9610612-2020-00125 (400468806 nr400z); 9610612-2020-00126 (400468807 nr870z); 9610612-2020-00127 (400468808 nr191z); 9610612-2020-00128 (400468809 nr192z).General information: we received a complaint regarding enduro components.This is one of 12 cases regarding "problems with enduro components", "implant loosening" and "black debris".Up to now, there are no devices available for investigation.Consequences for the patient: post-operative medical intervention was necessary: revision surgery.Investigation: no product at hand, therefore an investigation at the devices is not possible.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 definitive root cause for the failure at that time.Rationale: on the basis of the current information and without a product for investigation, a clear conclusion/root cause for the implant loosening can not be drawn.Corrective action: product safety case was created.

• Brand Name: AS TIBIA OFFSET STEM D15X52MM CEMENTED
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9963019
• MDR Text Key: 187799916
• Report Number: 9610612-2020-00128
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR192Z
• Device Catalogue Number: NR192Z
• Device Lot Number: 52463435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention