MAUDE Adverse Event Report: AESCULAP AG EXCIA PLASMAPORE-¿CAP 8/10 SIZE 12MM; HIP ENDOPROSTHETICS

Model Number AE-QAS-H546-34

Device Problem Fracture (1260)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Patient year of birth: (b)(6).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 a postoperative issue with a hip stem.The primary implantation occurred in 2010 with "domo via dorsal access path cement-free.Ceramic-ceramic sliding pairing".The ceramic inlay was broken in 2017 and a second surgery occurred.Replacements were implanted (cup change on continuum cup from zimmer trabecular metal + keramik inlay incl.Cup change on merete head 36/l).On (b)(6) 2019 while sitting down, the patient felt immobilizing pain in the area of the right hip; a fall did not occur.A revision procedure was planned due to cone fracture of the 8/10 cone of an excia stem.It was noted that the patient had already felt pain during every-day activities.The immobility happened after the cone fracture.Details about the revision were not provided; the explanted stem is in possession of the patient.

Manufacturer Narrative

Manufacturing evaluation: up until now, there are no devices available for investigation.Investigation: no product at hand.Therefore an investigation is not possible.There are no pictures available.Batch history review: due to the circumstance that the lot number is not available, we checked all lot numbers from the products which were delivered to the facility from 2009-2010.The device quality and manufacturing history records have been checked for all mentioned lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available it is not possible to determine a root cause for the failure.It could be possible that the failure is patient/usage related.Rationale: in light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a root cause for the mentioned failure.At that time we exclude a design related error because the market feedback is unremarkable on this matter.It could be possible that the breakage resulted due to an overload situation.Furthermore, it could be possible that the tiniest damages on the stem neck (for example from rf instruments during the mentioned revision of the broken ceramic inlay in 2017), may also have led to a supporting fracture situation.

Event Description

In the meantime we received new information from the hospital: primary implantation date: (b)(6)2007.First revision due to ceramic inlay breakage and cup loosening: 2017-03-09 second revision due to fracture of the stem: (b)(6)2019.Fractured stem: schaft excia gr.12 fa.Aesculap, 8/10er konus" involved component: kopf merete 8/10l (36) neutral" based on the information schaft excia gr.12 fa.Aesculap, 8/10er konus", the material number of the stem is most probably nc412t.Ae-qas-compet-imp is no implants from competitors.Involved components: 500456112 nc412t 500467836 ae-qas-compet-imp (no.Qas implants from competitors.).

Manufacturer Narrative

B5: description update d section: updated product information g5: 510k manufacturing side we received a complaint about an excia stem from the sozialstiftung bamberg.Up to now, there are no devices available for investigation.In the meantime we received new information from the hospital: primary implantation date: (b)(6)2007 first revision due to ceramic inlay breakage and cup loosening: (b)(6)2017 second revision due to fracture of the stem: 2019-02-13 fractured stem: schaft excia gr.12 fa.Aesculap, 8/10er konus" involved component: kopf merete 8/10l (36) neutral" based on the information schaft excia gr.12 fa.Aesculap, 8/10er konus", the material number of the stem is most probably nc412t.Ae-qas-compet-imp is no implants from competitors.The aesculap product nv412t together with a merete product is a no approved combination post-operative medical intervention was necessary -> revision surgery.No product at hand.Therefore an investigation is not possible.Due to the circumstance that the lot number is not available, we checked all lot numbers from the products nc412t, which were delivered to the hospital sozialstiftung bamberg in the years (b)(6) and (b)(6).No similar incidents have been filed with products from these batches.Conclusion and root cause based on the information available it is not possible to determine a root cause for the failure.It could be possible that the failure is patient / usage related.Rationale in the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a root cause for the mentioned failure.At that time we exclude a design related error because the market feedback is unremarkable on this matter.It could be possible that the breakage resulted due to an overload situation.Corrective action a corrective action and preventive action is not necessary.

• Brand Name: EXCIA PLASMAPORE-¿CAP 8/10 SIZE 12MM
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8874364
• MDR Text Key: 153689706
• Report Number: 9610612-2019-00534
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K060437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

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: AE-QAS-H546-34
• Device Catalogue Number: AE-QAS-H546-34
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 10/25/2019
• Supplement Dates FDA Received: 09/05/2019; 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention