MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T5 LM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number NO166Z

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

Patient Problems Arthritis (1723); 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 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, no188z.

Manufacturer Narrative

Manufacturing evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

No updates.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T5 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: 11102410
• MDR Text Key: 224753460
• Report Number: 2916714-2020-00735
• 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: 12/31/2020,04/16/2020

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: NO166Z
• Device Catalogue Number: NO166Z
• Device Lot Number: 52048032
• 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: 86 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL474 - LOT # 52022235; NO188Z - LOT #51986760
• Patient Outcome(s): Required Intervention