MAUDE Adverse Event Report: AESCULAP AG METHA ¿CAP 12/14 130°/0° SIZE 4; HIP ENDOPROSTHETICS

Model Number NC274T

Device Problem Expiration Date Error (2528)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a metha cap 12/14 130°/0° size 4.(part # nc274t) was implanted during a total hip replacement procedure performed on (b)(6) 2021.According to the complainant, following the procedure, it was discovered that the implant was expired.Reportedly, during the procedure, the sales representative confirmed the size and expiration date (exp 11-30-2024) with the circulator in the room.The implants were then opened and implanted.However, upon entering the usage information into the device tracking system, the sales representative was prompted with a warning that the product was expired.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

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.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: METHA ¿CAP 12/14 130°/0° SIZE 4
• 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: 13017776
• MDR Text Key: 282343646
• Report Number: 9610612-2021-00761
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 04046963347239
• UDI-Public: 4046963347239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NC274T
• Device Catalogue Number: NC274T
• Device Lot Number: 52101027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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