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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK MOD CON DIST STEM 16 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-CORK MOD CON DIST STEM 16 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 6276-7-016
Device Problems Unstable (1667); Malposition of Device (2616)
Patient Problems Injury (2348); Joint Laxity (4526)
Event Date 06/08/2020
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 instability.Surgeon reported his suspicion that the proximal cone body was probably not fully seated during the primary implantation.The proximal cone body, biolox ceramic head, and 36d 0° insert were revised to a proximal cone body, lfit v40 head, size d constrained insert, and a dall-miles grip plate with cables.Rep provided usage sheets for the primary and revision surgeries, pictures of the explants, and confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event an event regarding malposition involving a restoration modular body was reported.The event was not confirmed.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following:the photos provided show a significant amount of blood on the the explanted modular body.There is also some evidence of bone ingrowth on the ha coated portion of the device.There is nothing else remarkable to note.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not available.
 
Event Description
It was reported that the patient's left hip was revised due to instability.Surgeon reported his suspicion that the proximal cone body was probably not fully seated during the primary implantation.The proximal cone body, biolox ceramic head, and 36d 0° insert were revised to a proximal cone body, lfit v40 head, size d constrained insert, and a dall-miles grip plate with cables.Rep provided usage sheets for the primary and revision surgeries, pictures of the explants, and confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
MOD CON DIST STEM 16 X 155 MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NJ NA
EI  NA
MDR Report Key10194103
MDR Text Key196389226
Report Number0002249697-2020-01296
Device Sequence Number1
Product Code LPH
UDI-Device Identifier04546540643742
UDI-Public04546540643742
Combination Product (y/n)N
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model Number6276-7-016
Device Catalogue Number6276-7-016
Device Lot NumberCAXV33AA
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
Patient Weight68
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