MAUDE Adverse Event Report: AESCULAP AG EXCIA T PLASMAPORE 12/14 SIZE 11MM; HIP ENDOPROSTHETICS

Model Number NU211T

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/31/2024

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 nu211t, excia t plasmapore 12/14 size 11mm.According to the complaint description, the neck broke postoperatively.It was noted, to be firmly integrated.The stem was replaced with a non-aesculap head, due to deep post-sintering and 12/22 gait disturbance.A revision was necessary.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, this event is considered reportable for the following reason: serious injury (report not later than 30 days).The assessment for the reportability of this adverse event was based on patient harm, revision.Additional information was not provided, nor available.The adverse event is filed under internal aesculap ag ref.No.(b)(4).

Event Description

Update: involved components: nv202e - vitelene insert f 32mm sym.(internal aesculap ag ref.No.(b)(4)) nv150t - plasmafit plus cup size 50mm f(internal aesculap ag ref.No.(b)(4)) uknown implants from competitors (internal aesculap ag ref.No.(b)(4)).

Manufacturer Narrative

Additional information: b5 - involved components added.B7 - medical history added.D9 - product return.D10 - involved components.H3 - yes, product evaluated.H6 - codes updated.Investigation results: visual inspection: during the examination it could be observed that the neck of the prostesis is broken off.The surface of the broken off neck of the stem shows several black dots.The proximal area of the shaft shows signs of the explantation.The fracture surface shows a fatigue fracture area and a forced fracture area.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.There are no other similar complaints within these batches.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Conclusion/preventive measures: based upon the above-mentioned investigation results, a definitive root cause cannot be established.There are no hints for a material or manufacturing problem.One reason for breakage could be that during the surgery, a contact at the neck of the stem could have been made with the instruments leading as mentioned above to the several black dots.As the strength of the material is reduced at these points, the breakage could have taken place.Based upon investigation results, a capa is not necessary.

• Brand Name: EXCIA T PLASMAPORE 12/14 SIZE 11MM
• Type of Device: HIP 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: 19168381
• MDR Text Key: 340899901
• Report Number: 9610612-2024-00127
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NU211T
• Device Catalogue Number: NU211T
• Device Lot Number: 52369712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2017
• 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: NV150T - LOT 52575551; NV202E - LOT 52779019; UNKNOWN IMPLANTS FROM COMPETITORS
• Patient Outcome(s): Required Intervention