MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR ROTATION KNEE FEMORAL COMPONENT

Model Number 15-2813/11

Device Problems Disconnection (1171); Incomplete or Inadequate Connection (4037)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/18/2018

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 complaint sample was returned on (b)(6) 2018.The investigation is in process.

Event Description

Femoral component disassociated from stem almost eight months after surgery.No obvious reason.No prosthetic fracture.

Event Description

Femoral component disssociated from stem almost eight months after surgery.No obvious reason.No prosthetic fracture.

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 femoral component and the femoral segment were available for the visual investigation.Residues are visible at the taper of the femoral component.The locking screw in the taper is abraded.Residues could not be washed away and indicate that the stem was not fixed correctly.Metal abrasion is indicated.A new sample stem is loose on the taper and cannot be introduced as intended due to residues.Bone cement is visible at the femoral segment.One securing pin of the modular stem was found broken in the bone cement.The second broken securing pin of the modular stem was found loose in the bag.The modular stem was not provided for investigation.The plateau showed no deviation.Traces of unusual damage indicate that the modular stem may have wedged at the taper connection initially and wasn't placed at the intended position.As a result, the connection loosened and the securing pins and the locking screw were damaged by rotational movements subsequently.Furthermore the patient has a bmi of 30.5 and an amputation on the other side.According to the quality documentation review and the investigation results a quality issue is not assumed.

• Brand Name: ENDO-MODEL MODULAR ROTATION KNEE FEMORAL COMPONENT
• Type of Device: ENDO-MODEL MODULAR ROTATION KNEE FEMORAL COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 7937433
• MDR Text Key: 122799417
• Report Number: 3004371426-2018-00011
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 15-2813/11
• Device Catalogue Number: 15-2813/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 110