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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL REPLACEMENT SET ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL REPLACEMENT SET ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 15-0027/14
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
The reporting obligation was re-evaluated based on an update of the risk assessment as of (b)(6) 2021. As a remedial action to address the mix-up of the two production orders, a recall of the two affected lots was initiated. The us is not affected by the recall of the two lots. A capa is in process.
 
Event Description
It was reported that a tibial plateau did not fit intraoperatively. The surgeon used another tibial plateau that was available. No health consequence was reported. Further investigation showed that the package contained tibial plateaus with size medium instead of size small due to a mix-up of two production orders.
 
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Brand NameENDO-MODEL REPLACEMENT SET
Type of DeviceROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
rebekka winterhoff
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key12876867
MDR Text Key282549362
Report Number3004371426-2021-00033
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number15-0027/14
Device Lot Number2139091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2021
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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