MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F4 LM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number NO188Z

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

Patient Problem Arthritis (1723)

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 to aesculap inc.That a univation x unicondylar knee arthroplasty system was implanted during a primary surgery performed on an unknown date.According to the complainant, the patient underwent a revision surgery 1863 days after the primary surgery due to osteoarthritis.The device was not available to be returned to the manufacturer for evaluation.The surgeon provided additional information which revealed the following cement technique: "cement holes were drilled in both femur and tibia.Cement was applied with finger pressure to the bone and to the components.Tibial component impacted and excess cement cleared.Femoral component impacted and excess cement cleared.Trial surface was placed and knee brought into extension with tongue depressor for pressurization.Cement allowed to cure prior to placing final poly." no known patient complications following the revision surgery.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nl474.Associated medwatch-reports: 9610612-2021-00023 (400499147 (b)(4)).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2021-00023 ((b)(4) no166z); 9610612-2021-00024 ((b)(4) no188z).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.The provided pictures show that only partly bone cement residues adhesive on the intended area of the femoral- and tibial component.It should be noted that the explants in the pictures provided do not correspond to the batch number and reference code listed in the complaint.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are 2 similar complaints against the same lot number (51986760).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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Event Description

Involved component: nl474 - univation f meniscal comp.T5 rm/lm 7mm - 52022235.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 LM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11245985
• MDR Text Key: 233040639
• Report Number: 9610612-2021-00024
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046964053658
• UDI-Public: 4046964053658
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 51986760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL474-52022235.; NL474-52022235.
• Patient Outcome(s): Required Intervention