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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION, SMALL ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION, SMALL ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 16-2840/02
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/26/2021
Event Type  Injury  
Event Description
On 2021-06-29, linkbio complaints department was notified of a revision surgery that took place on (b)(6) 2021 to address a dislocation of a failed connection component (part # 16-2840/02, sn # (b)(4)). As per the sales representative, "the bushings and spring were behind the implants in the back of the joint". This report concerns the same patient as report 3006721341-2020-00002 and 3006721341-2019-00007.
 
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Brand NameCONNECTION COMPONENT ROTATIONAL VERSION, SMALL
Type of DeviceROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
MDR Report Key12193772
MDR Text Key262406731
Report Number3006721341-2021-00004
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-2840/02
Device Catalogue Number16-2840/02
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/29/2021
Device Age18 MO
Event Location No Information
Date Report to Manufacturer06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/19/2021 Patient Sequence Number: 1
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