MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ROTATIONAL KNEE PROSTHESIS ENDO-MODEL-M

Model Number SA-KG-N109-L-G/ZRN

Device Problems Device Appears to Trigger Rejection (1524); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hypersensitivity/Allergic reaction (1907); Joint Laxity (4526)

Event Date 05/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the clinical research coordinator at ucsf informed t.P.That the zrn-coated tka device implanted under compassionate use provisions (b)(4) had been explanted in (b)(6) 2022 due to titanium allergy and loosening.

Event Description

On (b)(6) 2022, the clinical research coordinator at ucsf informed t.P.That the zrn-coated tka device implanted under compassionate use provisions (comp-017) had been explanted in december 2022 due to titanium allergy and loosening.Updated 20230606: cause for revision was aseptic loosening; patient outcome is good - revision was successful, to a more traditional implant with ti in a non articular part of the implant (the stem).Updated 20230608: additional information received per surgeon: the revision was not due to ti allergy/loosening but only to cement loosening and the cement loosening was: for the femur at both the cement/device and cement/bone interfaces, and for the tibia at the cement/bone interface only.

• Brand Name: ROTATIONAL KNEE PROSTHESIS ENDO-MODEL-M
• Type of Device: ROTATIONAL KNEE PROSTHESIS ENDO-MODEL-M
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17071121
• MDR Text Key: 316625898
• Report Number: 3006721341-2023-00013
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SA-KG-N109-L-G/ZRN
• Device Catalogue Number: SA-KG-N109-L-G/ZRN
• Device Lot Number: 130418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2023
• Distributor Facility Aware Date: 05/23/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG