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

Model Number 15-8522/55

Device Problems Crack (1135); Degraded (1153); Fracture (1260); Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Joint Laxity (4526)

Event Date 07/28/2022

Event Type  Injury  

Event Description

Fracture.

Manufacturer Narrative

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

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

Fracture.

• Brand Name: MEGASYSTEM-C
• Type of Device: MODULAR STEM CEMENTLESS
• 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: 15231110
• MDR Text Key: 297953085
• Report Number: 3004371426-2022-00029
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575412242
• UDI-Public: 04026575412242
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 15-8522/55
• Device Catalogue Number: 15-8522/55
• Device Lot Number: 1437123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 125 KG