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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE 1 HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE 1 HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Corroded (1131); Material Deformation (2976); Appropriate Term/Code Not Available (3191)
Patient Problems Anemia (1706); Swelling (2091); Injury (2348); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/14/2016
Event Type  Injury  
Manufacturer Narrative
An event regarding alleged ¿pain and swelling¿ involving an unknown accolade stem was reported. The reported event for corrosion was confirmed based on material analysis report for the metal head. Device evaluation and results: not performed as the device was not returned. Medical records received and evaluation: a review of provided revision operative report, lab reports, and material analysis of the explanted metal head on the left hip by a clinical consultant by a clinical consultant indicated ¿no complete clinical or past medical history or patient demographics are available. There are no x-rays available for review and no serum cobalt and chromium levels or mars mri images of either hip. There is no examination of the right hip explanted components and no histologic slides available for evaluation. After multiple revisions to both hips, compromised soft and bony tissue and possible infection, histologic diagnosis confirming trunnionosis as the source of pathology and histologic findings is properly listed as ¿opinion¿. Review of additional documentation and review of histologic slides is required to evaluate this case. ¿ device history review: not performed as the device was not properly identified. Complaint history review: not performed as the device was not properly identified. Conclusions: the reported event for corrosion was confirmed based on review of the material analysis report of the metal head stating that "eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material. " the root cause could not be determined based on review of the provided revision operative report, and lab reports by a clinical consultant indicated: ¿no complete clinical or past medical history or patient demographics are available. There are no x-rays available for review and no serum cobalt and chromium levels or mars mri images of either hip. There is no examination of the right hip explanted components and no histologic slides available for evaluation. After multiple revisions to both hips, compromised soft and bony tissue and possible infection, histologic diagnosis confirming trunnionosis as the source of pathology and histologic findings is properly listed as ¿opinion¿. Review of additional documentation and review of histologic slides is required to evaluate this case. ¿ not available.
 
Event Description
The patient underwent left hip revision surgery of an accolade 1 and lfit head due to trunnionosis. Reported hip swelling, difficulty in mobilising due to pain in hip, low energy and anaemia.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The patient underwent revision surgery of an accolade 1 and lfit head due to trunnionosis. Reported hip swelling, difficulty in mobilising due to pain in hip, low energy and anaemia.
 
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Brand NameUNKNOWN ACCOLADE 1
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6241001
MDR Text Key253722424
Report Number0002249697-2017-00167
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
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 Received10/30/2017
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: 01/11/2017 Patient Sequence Number: 1
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