MAUDE Adverse Event Report: AESCULAP AG METHA NECK 12/14 135/0; HIP ENDOPROSTHETICS

Model Number NC088K

Device Problem Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 02/11/2021

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 nc088k - metha neck 12/14 135¿/0¿.According to the complaint description, the metallosis with large osteolyses behind the acetabulum and on the proximal femur, clear corrosion signs on the plug connection between the head-neck-cone and the neck-stem-cone.The inlay is completely worn out within 6 years.The explants are kept by the patient at her express request.Implantation: 2008, (b)(6) nc081t, nc088k, nh050t, nh202, nk529k.Revision (b)(6) 2015: htep: only change of head and inlay; nh202, 51953832 + smith and nephew biolex option kopf 32s-12/14m sterile (3849717694582, 7010877872).Revision (b)(6) 2021: htep: complete change (stem, cup and inlay) due to wear.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00170 ((b)(4) + nc081t).Involved components: nh050t plasmacup sc size 50mm 51484353.Nh202 sc/msc pe-insert 32mm 48/50 sym.51953832.Ae-qas-compet-imp collect.No.Qas implants from competitors.

Event Description

Associated medwatch: 9610612-2021-00170 ((b)(4)+ nc081t).Involved components: nh050t - plasmacup sc size 50mm - 51484353; nh202 - sc/msc pe-insert 32mm 48/50 sym.- 51953832; ae-qas-compet-imp - collect.No.Qas implants from competitors - unknown.

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.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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 NECK 12/14 135/0
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11495657
• MDR Text Key: 254017434
• Report Number: 9610612-2021-00169
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 04046963183745
• UDI-Public: 4046963183745
• Combination Product (y/n): N
• PMA/PMN Number: K071916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: NC088K
• Device Catalogue Number: NC088K
• Device Lot Number: 51484995
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-QAS-COMPET-IMP - UNKNOWN.; AE-QAS-COMPET-IMP - UNKNOWN.; NH050T - 51484353.; NH050T - 51484353.; NH202 - 51953832.; NH202 - 51953832.; NH050T - 51484353; NH202 - 51953832; NH202 - 51953832
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR