MAUDE Adverse Event Report: AESCULAP AG TIBIA OFFSET STEM D16X92MM CEMENTLESS; KNEE ENDOPROSTHETICS

Model Number NR176K

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 01/29/2021

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 nr176k - tibia offset stem d16x92mm cementless.According to the complaint description, the primary surgery of total knee arthroplasty was performed on the (b)(6) 2018 with a non-aesculap implant.On the date of (b)(6) 2019 a revision surgery with our product was necessary.The implant caused a rigidity which led to an additional revision surgery.The surface rigidity was probably caused by the polyethylene on tibia.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00135 ((b)(6) - nr176k); 9610612-2023-00136 ((b)(6) - nr612m); 9610612-2023-00137 ((b)(6) - nr071k).

Manufacturer Narrative

Additional information: h6 - codes updated.Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Device history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are 0 similar complaints against the same lot number.Explanation and rationale: in this case the product risk analysis (pra) is only conditionally applicable because the definitive root cause for the mentioned rigidity is unclear and we assume that the used implants are primarily not the root cause of the mentioned rigidity.Conclusion and preventive measures: on the basis of the current information a clear conclusion and root cause 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

Associated medwatch-reports: 9610612-2023-00135 ((b)(4) - nr176k).9610612-2023-00136 ((b)(4) - nr612m).9610612-2023-00137 ((b)(4) - nr071k).Involved components: nr004k/columbus rev f femur cemented f4l-lot 52430574.Nr293k/femur extens.Stem 6° d18x77mm cemented - lot 52428912 nr464k/columbus rev femur spacer distal f4 5mm - lot 52501921.Nr244k/columbus tib.Hemi-spcr.T1/1+ 5mm rl/lm - lot 52405938.Nr044k/columbus tib.Hemi-spcr.T1/1+ 5mm rm/ll - lot 52322200.Nx041/patella 3-pegs p1 - lot 52497774.Nr400k/nut f/femur extens.Stem all sizes neutr.- lot 52510235.

Event Description

Associated medwatch-reports: 9610612-2023-00135 (400603043 - nr176k), 9610612-2023-00136 (400603040 - nr612m), 9610612-2023-00137 (400603039 - nr071k).Involved components: nr004k/columbus rev f femur cemented f4l-lot 52430574.Nr293k/femur extens.Stem 6° d18x77mm cemented - lot 52428912.Nr464k/columbus rev femur spacer distal f4 5mm - lot 52501921.Nr244k/columbus tib.Hemi-spcr.T1/1+ 5mm rl/lm - lot 52405938.Nr044k/columbus tib.Hemi-spcr.T1/1+ 5mm rm/ll - lot 52322200.Nx041/patella 3-pegs p1 - lot 52497774.Nr400k/nut f/femur extens.Stem all sizes neutr.- lot 52510235.

• Brand Name: TIBIA OFFSET STEM D16X92MM CEMENTLESS
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17015409
• MDR Text Key: 316196297
• Report Number: 9610612-2023-00135
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K083772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: NR176K
• Device Catalogue Number: NR176K
• Device Lot Number: 52499419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NR004K-LOT 52430574; NR004K-LOT 52430574; NR044K - LOT 52322200; NR044K - LOT 52322200; NR244K - LOT 52405938; NR244K - LOT 52405938; NR293K - LOT 52428912; NR293K - LOT 52428912; NR400K - LOT 52510235; NR400K - LOT 52510235; NR464K - LOT 52501921; NR464K - LOT 52501921; NX041 - LOT 52497774; NX041 - LOT 52497774
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 66 KG