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U.S. Department of Health and Human Services

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

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AESCULAP AG EXCIA PLASMAPORE-¿CAP 8/10 SIZE 12MM HIP ENDOPROSTHETICS Back to Search Results
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.
 
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Brand NameEXCIA PLASMAPORE-¿CAP 8/10 SIZE 12MM
Type of DeviceHIP ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key8874364
MDR Text Key153689706
Report Number9610612-2019-00534
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K060437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
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
Date FDA Received08/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAE-QAS-H546-34
Device Catalogue NumberAE-QAS-H546-34
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/08/2019 Patient Sequence Number: 1
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