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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,

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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, Back to Search Results
Model Number 509-02-58F
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

It was reported that the patient's left hip was revised due to dislocation of the adm/mdm poly insert from the mdm metal liner. The surgeon also wanted to medialize the acetabular shell. The mdm/ adm liner construct, ceramic head, sleeve (implanted (b)(6) 2019) and acetabular shell with 5 screws (implanted (b)(6) 2019) were revised to a larger shell, reimplantation of the 5 original screws (rep notified surgeon that this was off-label use), and femoral head with constrained liner. Rep confirmed there are no allegations against the revised head and sleeve, and confirmed that no further information will be available.

 
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Brand NameTRITANIUM REVISION ACETABULAR
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9639815
MDR Text Key188644719
Report Number0002249697-2020-00166
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number509-02-58F
Device Catalogue Number509-02-58F
Device LOT Number496JRA
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 Received12/31/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2017
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: 01/28/2020 Patient Sequence Number: 1
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