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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL SL KNEE PROSTHESIS SYSTEM; CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
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WALDEMAR LINK GMBH & CO. KG ENDO MODEL SL KNEE PROSTHESIS SYSTEM; CONNECTION COMPONENT ROTATIONAL VERSION, SMALL Back to Search Results
Model Number 16-2840/02
Device Problems Device Slipped (1584); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/13/2022
Event Type  Injury  
Event Description
Linkbio complaints was notified on (b)(6) 2022 by sales rep (b)(6) that a revision surgery was performed by dr.(b)(6) because a connection component had a screw that was starting to back out.A ronguer had to be used to back it out.The connection component and the femoral component were replaced, as the femoral component was loose.The revision was performed because the patient had metallosis.Rep stated that they have seen it before, that they can see poly wear from the screw, and wear to the screw head and some tissue wear.
 
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Brand Name
ENDO MODEL SL KNEE PROSTHESIS SYSTEM
Type of Device
CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key15122154
MDR Text Key296791722
Report Number3006721341-2022-00005
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2022
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? Yes
Device Model Number16-2840/02
Device Catalogue Number16-2840/02
Device Lot Number201109/0157
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2022
Event Location Hospital
Date Report to Manufacturer07/15/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient SexFemale
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