MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T4 LM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number NO165Z

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

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results become available, a supplement will be provided.

Event Description

It was reported that there was an issue with the product univation x, unicondylar knee implant.The surgeon noted that a number of implants had loosened and required revision; possibly 2 in the last few months.When additional information is received, the complaint will be updated.Non-aesculap instruments were used during the revision.The adverse event is filed under reference (b)(4).

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 1468 days after the primary surgery due to implant loosening.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: no187z, nl473.

Manufacturer Narrative

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 explants the pictures provided do not correspond to the batch number (femoral component) and reference code (tibial component) listed in thecomplaint.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 no similar complaints have been filed against products from this batch number.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.The univation devices were affected in a recall initiated recently.

Event Description

Associated medwatch-reports: 2916714-2020-00735 ((b)(4)- no187z).Involved components: nl473 - univation f meniscal comp.T4 rm/lm 7mm - 51976008.No187z - as univation xf femur cemented f3 lm - 52024177.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T4 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: 11102425
• MDR Text Key: 224753287
• Report Number: 2916714-2020-00734
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2020,04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO165Z
• Device Catalogue Number: NO165Z
• Device Lot Number: 52108119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2020
• Distributor Facility Aware Date: 11/19/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL473 - LOT # 51976008; NL473-51976008; NO187Z - LOT # 52024177; NO187Z - LOT # 52024177
• Patient Outcome(s): Required Intervention