MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CUSTOM MADE DEVICE; DISTAL FEMORAL REPLACEMENT

Model Number 11C001957313-05017

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377)

Event Date 12/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2023 notified about patient being in the hospital for sepsis.The date of surgery occurred on (b)(6) 2022 and the patient developed sepsis thereafter although the exact date of event is unknown.[distributor].Failed right total knee replacement with wear and debris [surgery report (b)(6) 2023].

Manufacturer Narrative

The review of the device history records showed no deviations.All product features and sterilization documents corresponded with the valid specifications of the (b)(4).At the time period, when the item was produced.

Event Description

Failed right total knee replacement with wear and debris (.) evidence of subsidence of the tibial component, multidirectional instability [follow-up report of the clinic 24.02.2023] on 2/7/2023 notified about patient being in the hospital for sepsis.The date of surgery occurred on (b)(6) 2022 and the patient developed sepsis thereafter although the exact date of event is unknown.[distributor].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: DISTAL FEMORAL REPLACEMENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16599213
• MDR Text Key: 311859157
• Report Number: 3004371426-2023-00015
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/21/2023

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 Model Number: 11C001957313-05017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 79 KG