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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of (b)(4) at the time, when the item was produced.Even after several requests no further information regarding this incident has been submitted.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

Translation: breakage of taper between condyle component and femoral stem.

• Brand Name: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
• Type of Device: ROTATIONAL 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 Key: 8296637
• MDR Text Key: 134723695
• Report Number: 3004371426-2019-00077
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 02/01/2019
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR