MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS WITH ANTI-LUXATION DEVICE, TIBIAL PLATEAU; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-0027/17

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/12/2014

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 30,8 and indicates obesity in first stage.Obesity is with regards to our instruction for use a relative contraindication.An insufficient constitution of soft tissue may have contributed to an overload of implant components.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

Translation: insufficiency of knee mechanism at the tibial plateau.Therewith exchange of inlay.(hospital (b)(6)).

• Brand Name: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS WITH ANTI-LUXATION DEVICE, TIBIAL PLATEAU
• 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: 8296492
• MDR Text Key: 134712991
• Report Number: 3004371426-2019-00007
• 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: 01/14/2015

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
• Device Expiration Date: 11/06/2018
• Device Model Number: 15-0027/17
• Device Catalogue Number: 15-0027/17
• Device Lot Number: 1343216
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74