MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL MODULAR KNEE PROTHESIS SYSTEM; FEMORAL SPACER, S4,80 MM, LARGE, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM

Model Number 15-2964/06

Device Problems Unintended Movement (3026); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994)

Event Date 04/27/2023

Event Type  Injury  

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

Dr.M indicates that the patient needs femoral-side revision due to pain and audible clicking that dr.M believes is related to movement at the uhmwpe femoral augment.[customer].

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

Surgeon indicates that the patient needs femoral-side revision due to pain and audible clicking that surgeon believes is related to movement at the uhmwpe femoral augment[customer].

• Brand Name: ENDO MODEL MODULAR KNEE PROTHESIS SYSTEM
• Type of Device: FEMORAL SPACER, S4,80 MM, LARGE, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17548376
• MDR Text Key: 321147259
• Report Number: 3004371426-2023-00077
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04026575205912
• UDI-Public: 04026575205912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 15-2964/06
• Device Catalogue Number: 15-2964/06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2023
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 109 KG