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

Model Number 15-8522/65

Device Problems Detachment of Device or Device Component (2907); 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 (b)(4) at the time, when the item was produced.

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 on (b)(6) 2019.(case 1).On (b)(6) 2019, the patient was readmitted for an identical development: broken segment, broken + loosen screws, mobilized implant.The item was revised again, both segments of the implant and screws were replaced.(case 2).

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.

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 on (b)(6) 2019.(case 1).On (b)(6) 2019, the patient was readmitted for an identical development: broken segment, broken + loosen screws, mobilized implant.The item was revised again, both segments of the implant and screws were replaced.(case 2).

• 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: 9353250
• MDR Text Key: 167347170
• Report Number: 3004371426-2019-00134
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 15-8522/65
• Device Catalogue Number: 15-8522/65
• Device Lot Number: 1545065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 02/25/2020
• 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