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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #7 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #7 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 6051-0730S
Device Problem Material Deformation (2976)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 11/18/2008
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted on into final stock with no reported discrepancies. There have been one more event for the lot referenced. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report. Device not available.

 
Event Description

Review of the medical review indicated, "on (b)(6) 2008 an exploration of the right total hip, incision and drainage, and vac dressing application was performed for a post-operative diagnosis of extensive metallosis right hip. The operative report describes a lateral approach and findings including metallosis of the right hip and thigh with damage and wear to the poly liner and head. Extensive metallosis around the proximal femoral component and behind the acetabular component was noted and the surgeon did not close the fascia and kept a sponge in the proximal femur and acetabulum after explanting the total hip components. On (b)(6) 2008 debridement was performed and a vac system was applied. Culture was noted to be positive for (b)(6). When seen on (b)(6) 2009, she was noted to be 6-centimeters short on the right lower extremity. " "on (b)(6) 2009 a right hip wound revision with incision and drainage and insertion of an antibiotic spacer was performed for an infected girdlestone with chronic osteomyelitis and particle disease of the right hip. " "on (b)(6) 2009 removal of the antibiotic spacer and conversion to a total hip arthroplasty was performed for a diagnosis of status-post removal infected total hip arthroplasty and antibiotic spacer. ".

 
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Brand NameSECUR-FIT MAX 132 HIP STEM #7
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7902504
MDR Text Key121493113
Report Number0002249697-2018-03009
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK051738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2013
Device Catalogue Number6051-0730S
Device LOT Number47DMLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/02/2008
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: 09/24/2018 Patient Sequence Number: 1
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