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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG UNKNOWN
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WALDEMAR LINK GMBH & CO. KG UNKNOWN Back to Search Results
Model Number UNKNOWN
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 12/01/2022
Event Type  Injury  
Event Description
Periprosthetic fracture and disconnection of the stem.
 
Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
 
Event Description
Periprosthetic fracture and disconnection of the stem.
 
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Brand Name
UNKNOWN
Type of Device
UNKNOWN
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
Manufacturer Contact
lisa effe
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key16041953
MDR Text Key306065400
Report Number3004371426-2022-00048
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/01/2022
Initial Date FDA Received12/23/2022
Supplement Dates Manufacturer Received12/01/2022
Supplement Dates FDA Received05/05/2023
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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