MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 8/10 22.2MM M; HIP ENDOPROSTHESES - HEADS

Model Number NJ112K

Device Problem Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00042 ((b)(4) nk022k).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 an isodur prosthesis head.On (b)(6) 2009, the patient underwent an initial bipolar hip arthroplasty procedure.On (b)(6) 2019, there was an emergent consultation due to dislocation of femoral head.X-ray results showed possible migration of the bipolar cup.Non-invasive repositioning of the femoral head was successfully performed.The patient was discharged the same day, but it was noted that there was still the possibility that the cup ring remained displaced.In addition, damage to the acetabulum was suspected.On (b)(6) 2020, a revision occurred.The bipolar cup and the femoral head were removed.The cup showed extreme wear, and the cup ring showed multiple dents, which likely occurred as a result of frequent neck impingement that was triggered by cup migration.The physician noted that the wear had occurred over a long period of time, and it had initially not been much of a concern.A revision surgery was necessary.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00042 ((b)(4) nk022k) - cup.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00041 ((b)(4) nj112k); 9610612-2020-00042 ((b)(4) nk022k).General information: we received a complaint about a nj112k - isodur prosthesis head 8/10 22.2mm m and a nk022k - bipolar cup id22.2mm od42mm self-center.According to the provided information it came to a dislocation of the femoral head post-operatively.We did not receive the components for investigation.Consequences for the patient: post-operative medical intervention was necessary à revision surgery.Investigation: no product at hand, therefore an investigation is not possible.Investigation: no product at hand, therefore an investigation is not possible.Conclusion and root cause: based on our experience, the failure is most probably patient or usage related.Rationale: due to the fact that we did not receive the components for investigation, a clear conclusion can not be drawn.Based on our experience and previous similar cases, we assume that the dislocation most likely occurred due to a neck-ring-impingement as also mentioned under 2.1 general information.Due to the mentioned cup migration (also 2.1 general information) such an impingement may have been triggered.An impingement between the neck of the metal stem and the pe-ring of the bipolar cup may lead to an opening of the ring, which can result in a dislocation of the ball head during specific movement sequences.A root cause for an impingement could be the mentioned cup migration or an inappropriate implantation situation.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: ISODUR PROSTHESIS HEAD 8/10 22.2MM M
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9813775
• MDR Text Key: 183099899
• Report Number: 9610612-2020-00041
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K042344
• 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: 05/27/2020

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: 03/31/2018
• Device Model Number: NJ112K
• Device Catalogue Number: NJ112K
• Device Lot Number: 51483576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR