MAUDE Adverse Event Report: AESCULAP AG METHA ¿CAP 12/14 120°/0° SIZE 1; HIP ENDOPROSTHETICS

Model Number NC291T

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

This is a similar device report, a similar device of the reported device was sold to us.The reported device is not marketed in the us.Investigation: 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 (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 no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the provided information and due to a lack of the complained product, a clear conclusion cannot be drawn.The x-ray pictures have been evaluated.No clear signs could be found which could give a hint regarding the dislocation.As noted, it is possible that soft tissue damage facilitated the dislocation.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 on the investigation results, a capa is not necessary.

Event Description

It was reported that there was an issue with (b)(4) - metha cap 12/14 120°/0° size 1.According to the complaint description, the implant dislocated postoperatively due to a patient fall.The original total hip arthroplasty (tha) had been on (b)(6) 2020.Multiple dislocations occurred since 2020 and were treated.An additional medical intervention was necessary.A revision was performed on (b)(6) 2022 and the stem head and liner were replaced.The adverse event is filed under aag reference (b)(4).Involved components: (b)(4) - plasmafit plus 3 cup cap size 56mm i - lot 52116693.(b)(4) - vitelene insert i 32mm sym.- lot 52278595.(b)(4) - biolox delta prosth.Head 12/14 32mm s - lot 52535718.

• Brand Name: METHA ¿CAP 12/14 120°/0° SIZE 1
• 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: 14240547
• MDR Text Key: 293561008
• Report Number: 9610612-2022-00106
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

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
• Device Operator: Health Professional
• Device Model Number: NC291T
• Device Catalogue Number: NC291T
• Device Lot Number: 52544813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• 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: NC856T - PLASMAFIT PLUS 3 CUP CAP SIZE 56MM I -; NK560D - BIOLOX DELTA PROSTH.HEAD 12/14 32MM S -; NV205E - VITELENE INSERT I 32MM SYM. - LOT 5227859
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male