MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO KG DIAPHYSIS PROSTHESIS; COUPLING FOR DIAPHYSEAL SPACER MEGASYSTEM C

Model Number 15-8522/65

Device Problems Break (1069); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time period, when the item was produced.The investigation is in process.

Event Description

Patient was readmitted for implant mobilisation and breakage two years after first surgery.Failed implant was partially revised - the broken segment and the screws + bolts were exchanged with new ones.[(b)(6) clinic (b)(6)].

Event Description

Patient was readmitted for implant mobilisation and breakage two years after first surgery.Failed implant was partially revised - the broken segment and the screws + bolts were exchanged with new ones.[spitalul clinic colentina].

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The visual investigation confirms a fractured safety ring of the coupling component.The tip of the coupling component is damaged.Deformed material is visible.One bore hole is damaged as well.The surface is polished partially by movement.The plastic plugs of screw locking device are visible at the screws.The tip of the coupling component got damaged either while implanting or due to disconnected components.Therewith the safety ring could have been damaged initially.The x-ray images show that the screws loosened in situ.This made the coupling instable and led the safety ring fracture secondarily because the load was transferred from the screwed system to the safety ring only.The coupling for diaphyseal spacer was in this case used for knee fusion.It cannot be identified retrospectively if the implantation or the patient condition / obese constitution (bmi of 33.9) correlated with the loosened screws.Therefore the root cause is incomprehensible.The modular bone and joint revision system megasystem-c is designed for tumor and revision surgery.The waldemar link gmbh & co.Kg is aiming for the highest product quality and trying to keep the failure rate as low as possible by means of the customer feedback.Permanent employee trainings and market surveillance are performed.

• Brand Name: DIAPHYSIS PROSTHESIS
• Type of Device: COUPLING FOR DIAPHYSEAL SPACER MEGASYSTEM C
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO KG; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 8577012
• MDR Text Key: 143935924
• Report Number: 3004371426-2019-00122
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 15-8522/65
• Device Catalogue Number: 15-8522/65
• Device Lot Number: 1641092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 110