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

Model Number 15-8030/11

Device Problems Break (1069); Degraded (1153)

Patient Problems Failure of Implant (1924); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

According to the user report, the article in question is 15-8030/11 sn (b)(4), which was also stated in the complaint report, but the tinbn knee was returned with article numbers 15-9024/12 and sn (b)(4).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: on (b)(6) 2016 the patient was examined due to increased pain after the last operation with knee prosthesis change on (b)(6) 2010.The knee joint blocks when standing up and starting up.The knee is over stretchable.There was a mediolateral foldability with unphysiological joint play in the socket mechanism.The right knee joint can only be bent against slight resistance, a mechanism that runs with difficulty.After explantation of the prosthesis on (b)(6) 2016, a fracture in the coupling mechanism/bushing damage to the prosthesis was observed.".

Event Description

Translation: on (b)(6) 2016 the patient was examined due to increased pain after the last operation with knee prosthesis change on (b)(6) 2010.The knee joint blocks when standing up and starting up.The knee is overstretched.There was a mediolateral foldability with unphysiological joint play in the socket mechanism.The right knee joint can only be bent against slight resistance, a mechanism that runs with difficulty.After explantation of the prosthesis on (b)(6) 2016, a fracture in the coupling mechanism/bushing damage to the prosthesis was observed.".

Manufacturer Narrative

According to the user report, the article in question is (b)(4),which was also stated in the complaint report, but the tinbn knee was returned with article numbers 15-9024/12 and sn (b)(4) the article (b)(4) is filed and investigated under (b)(4) (mdr 3004371426-2019-00069).The article (b)(4) and sn (b)(4) is now filed and investigated under (b)(4) (mdr 3004371426-2019-00127).

• Brand Name: LINK ENDO-MODEL® ROTATION KNEE JOINT PROSTHESIS - CEMENTABLE
• Type of Device: ROTATING HINGED TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8296672
• MDR Text Key: 134723772
• Report Number: 3004371426-2019-00069
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 15-8030/11
• Device Catalogue Number: 15-8030/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 06/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91