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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #8 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

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STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #8 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU Back to Search Results
Catalog Number 6052-0830S
Device Problems Degraded (1153); Device Damaged by Another Device (2915); Material Deformation (2976); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 07/19/2018
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 reported lot. There have been no other similar events for the sterile 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. Device not returned / not received.

 
Event Description

It was reported that patient's hip was revised due to impingement. Surgeon also reported suspicion of infection with evidence of poly wear cited as the cause. Intra-operatively, no visual evidence of poly wear was found. Patient was revised to a spacer including a 6 x 127 hfx stem. The trunnion of the stem was impinging with the cup. Sales rep believes that infection was confirmed to prompt implantation of a first stage antibiotic spacer.

 
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Brand NameSECUR-FIT MAX 127 HIP STEM #8
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7789288
MDR Text Key117305002
Report Number0002249697-2018-02559
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2012
Device Catalogue Number6052-0830S
Device LOT NumberDY3MPD
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 Received08/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2007
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: 08/16/2018 Patient Sequence Number: 1
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