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

Model Number 15-2816/11

Device Problem Crack (1135)

Patient Problem Failure of Implant (1924)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time period, when the product was delivered to the customer.The bmi of the patient was 38,7 and indicates obesity.Obesity is with regards to our instruction for use a relative contraindication and contributed to an overload of implant components.The complaint sample was not provided.According to the quality documentation review and the investigation results a product failure is not assumed.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

Change of broken rotational bushing.

• Brand Name: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
• Type of Device: ROTATING 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: 8303821
• MDR Text Key: 134969652
• Report Number: 3004371426-2019-00025
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2014
• Device Model Number: 15-2816/11
• Device Catalogue Number: 15-2816/11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2009
• 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: 60 YR
• Patient Weight: 93