MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIA HEMI-WEDGE T2 4MM RL/LM; KNEE ENDOPROSTHETICS

Model Number NB055K

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

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 nb055k - enduro tibia hemi-wedge t2 4mm rl/lm.According to the complaint description, the x-ray showed gap between the tibial augments and the tibia in the frontal view despite firmly screwed augments.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00516 ((b)(4) - nb012k), 9610612-2021-00535 ((b)(4) - nb045k), 9610612-2021-00536 ((b)(4) - nb055k).Involved components: nr378k - enduro femur spacer post/dist f2 8x4mm - lot 52559382, nr293k - femur extens.Stem 6° d18x77mm cemented - lot 52419503, nr883m - enduro meniscal component f2 16mm - lot 52658142, nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52648134, nk914 - imset resorb.Intramedullary plug 14mm - lot 52636327, nb015k - enduro femoral component cemented f2l - lot 52627005, nr195k - tibia offset stem d15x92mm cemented - lot 52648094, nk918 - imset resorb.Intramedullary plug 18mm - lot 52636332.

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.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.Based upon the investigations results a capa is not necessary.

• Brand Name: ENDURO TIBIA HEMI-WEDGE T2 4MM RL/LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12225634
• MDR Text Key: 263439754
• Report Number: 9610612-2021-00536
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB055K
• Device Catalogue Number: NB055K
• Device Lot Number: 52491679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NB015K - LOT 52627005; NK914 - LOT 52636327; NK918 - LOT 52636332; NR195K - LOT 52648094; NR293K - LOT 52419503; NR378K - LOT 52559382; NR400K - LOT 52648134; NR883M - LOT 52658142; NB015K - LOT 52627005; NK914 - LOT 52636327; NK918 - LOT 52636332; NR195K - LOT 52648094; NR293K - LOT 52419503; NR378K - LOT 52559382; NR400K - LOT 52648134; NR883M - LOT 52658142