MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 8/10 28MM M; HIP ENDOPROSTHESES - HEADS

Model Number NJ132K

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

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 nj132k - isodur prosthesis head 8/10 28mm m.According to the complaint description, the dissociation of a 28mm metal head within a bipolar head from the 8/10 taper post hip hemiarthroplasty.2nd procedure to revise hip was performed.The incident in question is with regards a right hip cemented hemiarthroplasty performed using an excia cemented stem with an 8/10 t aper, a short 28mm metal head and a 51mm bipolar hemiarthroplasty head.On post op xrays in theatre the hip was found to be subluxed/dislocated.A manipulation of the hip to reduce it was performed at which point there was a dissociation of the femoral head and the cemented stem.The bipolar head actually entered the pelvis, damaging a blood vessel.The trunnion of the femoral stem caused a bladder perforation.The metal bipolar head was retrieved from beneath the iliac muscle.At the time the trunnion was covered by a trial femoral head and the stem reduced to prevent the trunnion from damaging the acetabulum.The trial head also disconnected from the stem unexpectedly and entered the pelvis.This entered an area from which it was not possible to safely retrieve it.As a result of the post operative bleeding the patient required embolisation of the bleeding vessel as a separate procedure.My personal feelings of this incident is that it is a freak occurrence for which the stem and trunnion is not to blame.I believe the bipolar head caught on the anterior lip of the acetabulum when it dislocated and when the manipulation was attempted the subsequent pull on the lip acted to separate the head from the stem and subsequently buttonholed through the fascia into the pelvis.Clinical team to continue to monitor patient periodically.A revision surgery was necessary.The adverse event is filed under aag reference 100028007 (400511251).Associated medwatch-reports: 9610612-2021-00393 (400511252 + nj133k).9610612-2021-00386 (400511251 + nj132k).Involved components: nk093 - centralizer size 13mm - 52552408.

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.The provided x-ray figure shows at the time of recording a not ideal implantation situation.The bipolar cup cannot develop a sufficient fixation in this position.The root cause for the mentioned subluxed/dislocated hip is an inappropriate implantation situation.The circumstances why it was implanted in this way are unclear.It is possible that patient-related circumstances may have contributed to this.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.During investigation the leading an involved component changed.Therefore this report and its associated reports got a new structure.

Event Description

X-rays were provided for investigation by customer.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00530 ((b)(6) - nk051s).9610612-2021-00386 ((b)(6) - nj132k).9610612-2021-00393 ((b)(6) - nj133k).Involved components: nk093 - centralizer size 13mm.Nj333k - excia l cemented 8/10 size 13mm.

• Brand Name: ISODUR PROSTHESIS HEAD 8/10 28MM M
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11821431
• MDR Text Key: 265258670
• Report Number: 9610612-2021-00386
• 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: 07/29/2021

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 Model Number: NJ132K
• Device Catalogue Number: NJ132K
• Device Lot Number: 52638269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NJ333K; NK093; NK093- (B)(6).
• Patient Outcome(s): Required Intervention