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

Model Number 15-2811/11

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.The batch documentation review incl.The quality inspection reports did not reveal irregularities or deviations in the production process.The implant corresponds with our specifications.The visual inspection shows the uhmwpe bushing is worn at the distal edge.The customer was contacted several times for further information regarding this complaint.As the x-ray images and surgery reports were not provided, we have not been able to conduct a more comprehensive investigation to determine the root cause in this case.The bmi of the patient was 32.5 and may have contributed to the worn bushing.The waldemar link (b)(4) is aiming for the highest product quality and trying to keep the failure rate as low as possible by means of the customer feedback.Permanent employee trainings and market surveillance are performed.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

This was the second revision for this patient.The patient felt instable and loose.Once into the knee you could clearly see the poly housing had worn away and fractured.

• 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: 8296575
• MDR Text Key: 134722389
• Report Number: 3004371426-2019-00045
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/16/2016

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: 09/30/2018
• Device Model Number: 15-2811/11
• Device Catalogue Number: 15-2811/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 45 YR
• Patient Weight: 95