MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; MODULAR STEM

Model Number 15-8522/62

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 10/05/2022

Event Type  Injury  

Event Description

Hyperextension and fracture of diaphyseal spacer.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Hyperextension and fracture of diaphyseal spacer.

• Brand Name: MEGASYSTEM-C
• Type of Device: MODULAR STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15665114
• MDR Text Key: 302333497
• Report Number: 3004371426-2022-00040
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575383894
• UDI-Public: 04026575383894
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 15-8522/62
• Device Catalogue Number: 15-8522/62
• Device Lot Number: 1610046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: 75 YR
• Patient Sex: Male