MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM; CONNECTION COMPONENT ROTATIONAL VERSION, SMALL

Model Number 16-2840/02

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 07/13/2022

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

Linkbio complaints was notified on (b)(6) 2022 by sales rep r.S.That a revision surgery was performed by dr.Db because a connection component had a screw that was starting to back out.A ronguer had to be used to back it out.The connection component and the femoral component were replaced, as the femoral component was loose.The revision was performed because the patient had metallosis.Rep stated that they have seen it before, that they can see poly wear from the screw, and wear to the screw head and some tissue wear.[customer].

Event Description

Linkbio complaints was notified on 2022-07-15 by r.S., that a revision surgery was performed by dr.(b)(6) because a connection component had a screw that was starting to back out.A ronguer had to be used to back it out.The connection component and the femoral component were replaced, as the femoral component was loose.The revision was performed because the patient had metallosis.R.Stated that they have seen it before, that they can see poly wear from the screw, and wear to the screw head and some tissue wear.Scans and/or images have been requested.Updated 2022-10-14, information in phone call with (b)(6), confirmed that the explanted parts were discarded on the day of the surgery (b)(6) 2022.[customer].

• Brand Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Type of Device: CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
• 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: 15172988
• MDR Text Key: 297313236
• Report Number: 3004371426-2022-00028
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151008
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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: 57 YR
• Patient Sex: Female