MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE MODIFICATION; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-9024/12

Device Problem Degraded (1153)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

The article from this case 15-9024/12 and sn (b)(4) was investigated and evaluated initially under the reference (b)(4) (mdr 3004371426-2019-00069).At that time we were provided with a wrong complaint sample.Now the correct sample (15-8030/11 sn (b)(4)) was sent and evaluated under (b)(4) and mdr 3004371426-2019-00069.So a new reference number was assigned for the tinbn knee (15-9024/12 and sn (b)(4)) and completed under (b)(4) and mdr 3004371426-2019-00127.

Event Description

[translation]: bushing failure after 12 months.

• Brand Name: LINK ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE MODIFICATION
• 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: omid rahmatian ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8978841
• MDR Text Key: 157784916
• Report Number: 3004371426-2019-00127
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K152431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: 15-9024/12
• Device Catalogue Number: 15-9024/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 100