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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6276-1-025
Device Problem Metal Shedding Debris (1804)
Patient Problems Pain (1994); Swelling (2091)
Event Date 06/01/2011
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Patient has been experiencing pain, swelling, receiving pain shots to his hip, and his doctor informed him that he has metal artifacts in the soft tissue.
 
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Brand Name
25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
bradley curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7521552
MDR Text Key108487623
Report Number0002249697-2018-01472
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2016
Device Catalogue Number6276-1-025
Device Lot Number35494301
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/23/2018
Initial Date FDA Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age46 YR
Patient Weight82
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