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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ALL POLY TIBIA COLUMBUS CR DD T1 10MM KNEE ENDOPROSTHETICS

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AESCULAP AG ALL POLY TIBIA COLUMBUS CR DD T1 10MM KNEE ENDOPROSTHETICS Back to Search Results
Model Number NN1210
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Implant Pain (4561)
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 nn1210-all poly tibia columbus cr dd t1 10mm. According to the complainant, the patient underwent a right knee revision surgery after the primary surgery due to pain and instability. The 10 mm poly insert was replaced with a 16 mm insert. At the end of the revision procedure, it was noted that the patient was stable and had suitable flexion and extension. An additional intervention was required. Also, the product was discarded on site and the operative report is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameALL POLY TIBIA COLUMBUS CR DD T1 10MM
Type of DeviceKNEE 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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11281230
MDR Text Key230432165
Report Number9610612-2021-00048
Device Sequence Number1
Product Code JHW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNN1210
Device Catalogue NumberNN1210
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/04/2021 Patient Sequence Number: 1
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