MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M MODULAR STEM; KNEE STEM

Model Number 15-2951/13

Device Problems Break (1069); Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to breakage of the stem at the taper junction.

Event Description

It was reported that a revision surgery was performed due to breakage of the stem at the taper junction.

• Brand Name: ENDO-MODEL M MODULAR STEM
• Type of Device: KNEE STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8792267
• MDR Text Key: 151095767
• Report Number: 3004371426-2019-00125
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 15-2951/13
• Device Catalogue Number: 15-2951/13
• Device Lot Number: 1546026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention