MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F4 LM; KNEE ENDOPROSTHESES

Model Number NO188Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with no188z - as univation xf femur cemented f4 lm.According to the complaint description, the femur implant loosened 5 month and 15 days post surgery.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4) involved components nl473 - univation f meniscal comp.T4 rm/lm 7mm - lot 52439781.

Manufacturer Narrative

Section a: updated patients age.Visual investigation: the complaint devices were investigated visually and microscopically.In the delivered condition, there are no bone cement residues visible on the femoral component.The discolorations on the gliding surface of the femoral component are due to oxidation.Such changes in color have no effect on the function or properties of the coating.The meniscal components show several little imprints and scratches, which probably resulting from third body wear (bone chips and/or bone cement residues).Device history records (dhr): the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results there is capa is not necessary.Additional inspections and examinations were initiated.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 LM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10959817
• MDR Text Key: 219963054
• Report Number: 9610612-2020-00879
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52436705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL473 - LOT 52439781; NL473 - LOT 52439781
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR