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U.S. Department of Health and Human Services

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

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-2811/11
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 07/06/2016
Event Type  Injury  
Manufacturer Narrative
All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced. The batch documentation review incl. The quality inspection reports did not reveal irregularities or deviations in the production process. The implant corresponds with our specifications. The visual inspection shows the uhmwpe bushing is worn at the distal edge. The customer was contacted several times for further information regarding this complaint. As the x-ray images and surgery reports were not provided, we have not been able to conduct a more comprehensive investigation to determine the root cause in this case. The bmi of the patient was 32. 5 and may have contributed to the worn bushing. The waldemar link (b)(4) is aiming for the highest product quality and trying to keep the failure rate as low as possible by means of the customer feedback. Permanent employee trainings and market surveillance are performed. The report is delayed due to inconsistencies with regard to foreign event reporting to fda. After re-evaluation of the complaint we determined that it is reportable. We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
 
Event Description
This was the second revision for this patient. The patient felt instable and loose. Once into the knee you could clearly see the poly housing had worn away and fractured.
 
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Brand NameENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
Type of DeviceROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer (Section G)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
annerike kleine
barkhausenweg 10
hamburg, 
GM  
MDR Report Key8296575
MDR Text Key134722389
Report Number3004371426-2019-00045
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 08/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Model Number15-2811/11
Device Catalogue Number15-2811/11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/01/2019 Patient Sequence Number: 1
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