MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ISODUR PROSTHESIS HEAD 12/14 32MM XL; IMPLANTS STANDARD PROSTHESES HEADS

Model Number NK532K

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: received complaint about a nk532k - isodur prosthesis head 12/14 32mm.According to the provided information, it came to a revision surgery due to a metallosis.Primary surgery was performed on (b)(6) 2011, the first revision surgery was performed on (b)(6) 2012 and the second and final surgery was performed on (b)(6) 2018 due to the breakage of the ceramic insert.The components at this time have not be returned.Post-operative intervention was necessary.The device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication for a material defect of a manufacturing failure.After not receiving the product an investigation was still found necessary.After the breakage of the ceramic insert in the year 2012, the mentioned metal ball head as well as a pe-insert have been implanted.According to the ifu and common knowledge, it is not allowed to implant this combination after a ceramic fracture due to the risk of three-body wear.Due to three-body wear it is possible that a metal ball head abrades itself at ceramic fragments which get into the bearing after a ceramic fracture.A capa is not necessary.

Event Description

Country of complaint: (b)(6).It was reported of an implant using a isodur prosthesis head.According to the provided information, it came to a revision surgery due to a metallosis.

Event Description

Primary surgery was performed on (b)(6) 2011 in which a metha modular neck, metha stem, and modular head 12/14 (size 36 mm xl) were implanted in the patient's right hip joint: along with these components, a smith and nephew shell incl.Cover, ceramic insert standard, and cover for shell were implanted.The first revision surgery was performed on (b)(6) 2012 due to breakage of the smith and nephew ceramic insert.An x-ray showed that the ceramic insert had broken into many tiny fragments which were seen throughout the joint.After the hip pseudocapsel was incised, serosal fluid was drained and tiny ceramic pieces as well as some metal fragments were observed.The head was observed to have metal particles underneath it after luxation; the head was hammered and removed but the shaft remained well fixated.It was confirmed that the ceramic inlay was entirely destroyed.There was also a large area of metallosis in the acetabelum area.The many ceramic pieces were removed although some pieces were likely not able to be found.The cover for shell was in four pieces and they were then removed.Several products in total were removed and explanted including the smith and nephew ceramic insert, shell incl cover, and cover for shell, and the bbraun ceramic head.Then the joint was throughly irrigated and prepared for new implants.An isodur prosthetic head was implanted as well as smith and nephew pe insert standard and cover for shell; the metha modular neck and stem remained in the patient.The second and final surgery was on 14feb2018 due to suspected metallosis and three-body wear of several components including the isodur prosthetic head, and smith and nephew pe insert standard and cover for shell.Explantation of the isodur prosthetic head and smith and nephew pe insert standard was performed.Further translation and clarification have been requested.

Manufacturer Narrative

Corrected data: event description.Relevant labs/tests.Implanted date.Concomitant medical devices.Investigation: batch history review: no similar complaints registered against the same lot number.Conclusion and root cause: the failure is usage related.

• Brand Name: ISODUR PROSTHESIS HEAD 12/14 32MM XL
• Type of Device: IMPLANTS STANDARD PROSTHESES HEADS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7871003
• MDR Text Key: 120136764
• Report Number: 9610612-2018-00256
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K040191
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: NK532K
• Device Catalogue Number: NK532K
• Device Lot Number: 51826032
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/11/2018
• Device Age: 6 YR
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REF: 0030794, LOT: 08.086, SERIAL: (B)(4); REF: 0030859, LOT: C1210900; REF: NC086T, LOT: 51705523; REF: NC098K, LOT: 51387649
• Patient Outcome(s): Other; Required Intervention