MAUDE Adverse Event Report: AESCULAP AG METHA ¿CAP 12/14 120°/0° SIZE 2; HIP ENDOPROSTHETICS

Model Number	NC292T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a metha ¿cap 12/14 120¿/0¿ size 2 (part # nc292t) was used during an unknown procedure performed on.According to the complainant, when inserting the stem, a bone fracture occurred in the neck.The procedure was successfully completed using another manufacturers device.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Event or Problem Description
Update: the malfunction occurred during a total hip arthroplasty (tha) procedure performed on (b)(6), 2021.Reportedly, a size 2 rasp was used and the stem was also inserted, but the bone cracked during hammering.
Additional Manufacturer Narrative
Investigation - visual inspection: optically, signs of usage of erratic appearance can be found at the stem.Signs of usage and slight damages, especially on the pasmapore coating as well as at the neck area, can be found on the stem.These signs originated most likely from the intraoperative inserting and removal respectively.Besides that, no abnormalities can be found.Batch history review: the device quality and manufacturing hisotry records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specifiaction valid at the time of production.There are no similar complaints aginst the same lot number(s) with this error pattern.Explanation and rationale: based on the provided information and after the investigation, there is no indication for a material problem which led to the described failure pattern.The fracture of the bone is most likely not related to the prosthesis, but rather to the preparation and/or the patient's bone condition.Conclusion: product was not causal for reported failure pattern.Corrective action: based upon the investigations results a capa is not necessary.

• Brand Name: METHA ¿CAP 12/14 120°/0° SIZE 2
• Common Device Name: 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: 11787732
• Report Number: 9610612-2021-00364
• Device Sequence Number: 19848774
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 52636231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female