MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM, MODULAR STEM - CEMENTLESS; KNEE STEM

Model Number 15-2951/24

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is in process.

Event Description

It was reported that when the customer opened the implant box, the sterile packaging was found to be compromised.

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The complaint sample was returned for investigation with the secondary packaging.The reported damage of the sterile packaging is confirmed through investigation.The sterile packaging shows several signs of friction between the stem and the packaging.The transport securing device is no longer assembled to the stem.The secondary packaging shows several signs of transportation.The foam padding is missing in the secondary packaging.The damage indicates that the item was moved frequently and is suspected to have been caused by rough handling during transport.A review of the complaint database identified no further complaint regarding the article number and failure mode.No further investigation / action is deemed necessary.

Event Description

It was reported that when the customer opened the implant box , the sterile packaging was found to be compromised.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM, MODULAR STEM - CEMENTLESS
• Type of Device: KNEE STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8247243
• MDR Text Key: 133071678
• Report Number: 3004371426-2019-00002
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 15-2951/24
• Device Catalogue Number: 15-2951/24
• Device Lot Number: 1428147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1