MAUDE Adverse Event Report: WALDEMAR LINK GMBH CO. KG LINK END0-MODEL UNICONDYLAR SLED PROSTHESIS; LINK UNICONDYLAR SLED PROSTHESIS

Model Number 15-2030/01

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

Wear of the polyethylene plateau after approximately 8 months.

Manufacturer Narrative

All product features correspond with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.Unfortunately the complaint sample was not returned to us for further investigations.So an exact root cause for the failure cannot be determined.The adiposity of the patient (bmi: (b)(6)), which is described as a relative contra indication in our product catalogue, surely facilitated the wear of the polyethylene.During market surveillance of the product unicondylar sled prosthesis link - metal-backed tibial plateau endo-model 7 mm we received complaints about the wear of the uhmwpe-plateau.To ensure a high quality of supply, we discontinued out the metal-backed tibial plateau endo-model 7 mm.Our customer were informed about the field safety notice (fsn (b)(4)).This event occurred outside of the u.S.And involve a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., waldemar link (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).

• Brand Name: LINK END0-MODEL UNICONDYLAR SLED PROSTHESIS
• Type of Device: LINK UNICONDYLAR SLED PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH CO. KG; hamburg ; GM
• Manufacturer Contact: philipp kottman ; barkhausenweg 10; hamburg 22339 ; GM 22339 ; 053575432
• MDR Report Key: 4392191
• MDR Text Key: 17590461
• Report Number: 3004371426-2014-00013
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K954186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: 15-2030/01
• Device Catalogue Number: 15-2030/01
• Other Device ID Number: GMDN: 48068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SN-NR.: (B)(4); ART-NR.: (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR