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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK SADDLE PROSTHESIS
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WALDEMAR LINK GMBH & CO. KG LINK SADDLE PROSTHESIS Back to Search Results
Model Number 99-8007/11
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Failure of Implant (1924)
Event Date 03/10/2021
Event Type  Injury  
Event Description
While reviewing the surgeons request for custom pelvic implant and femoral head to mate with an existing link size 2 cemented femur, linkbio became aware of the failed link saddle prosthesis.On 2020-12-21, linkbio was notified that the original surgery (lt hemipelvectomy and reconstruction) was performed on (b)(6) 2021 in (b)(6).The original surgical report only mentions that a size 2 femoral component and a 100 mm body and saddle prosthesis were implanted, and the patient reported failure "about 2-3 years post implant (felt a clunk)".
 
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Brand Name
LINK SADDLE PROSTHESIS
Type of Device
LINK SADDLE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key11529166
MDR Text Key241057636
Report Number3006721341-2021-00001
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 03/18/2021,12/21/2020
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 Operator Health Professional
Device Model Number99-8007/11
Device Catalogue Number99-8007/11
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2021
Distributor Facility Aware Date12/21/2020
Date Report to Manufacturer12/23/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient Weight106
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