MAUDE Adverse Event Report: AESCULAP AG METHA CAP 12/14 120/0 SIZE 2; HIP ENDOPROSTHESES - STEMS

Model Number	NC292T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation.Investigation on going.Additional information investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with nc292t - metha ¿cap 12/14 120°/0° size 2.According to the complaint description, the implant was difficult to fix.Tha using the metha stem was conducted.During the surgery, the doctor rasped up to number 2 and inserted the real number 2.When the head was inserted after the reduction, the doctor felt a slight discomfort.He looked closely and found a crack in the back of his neck.Upon close visual inspection, the fracture line extended to the front of the lesser trochanter, and the product was removed.After that, it was replaced with the bicontact stem.He cut the bone again and proceeded with the rasp.Since there was no problem in fixing with bicontact, bicontact was inserted.The surgery was completed successfully.An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00141 (400502949 + nc292t), 9610612-2021-00142 (400502950 + nk560d).
Additional Manufacturer Narrative
Investigation results: visual investigation: the components have been analysed visually.The so called plasmapore surface of the metal stem shows some abraded areas, coming most likely from the inserting of the stem into the bone.Besides that, no abnormalities could be found.The ceramic ball head shows several small metal scratches.We suspect that these are secondary damages which occurred during or after the surgery.There is no indication for a product or material failure.There is no correlation between the reported failure and the provided components.It is possible that an insufficient preparation and/or bone quality led to the reported fracture of the trochanter.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.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results the root cause of the problem is most probably usage related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: METHA CAP 12/14 120/0 SIZE 2
• Common Device Name: HIP ENDOPROSTHESES - STEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11426495
• Report Number: 9610612-2021-00141
• Device Sequence Number: 2855153
• Product Code: LZO
• UDI-Device Identifier: 04046963914233
• UDI-Public: 4046963914233
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: NC292T
• Device Catalogue Number: NC292T
• Device Lot Number: 52511039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR