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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-CORK CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 1440-2011
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
 
Event Description
Primary procedure, left hip.It was reported that after impacting the shell, the impacting bolt was cold-welded into the shell and could not be removed.The construct was removed and another shell implanted with a screw.Surgery was completed successfully with a delay of approximately 10 minutes.
 
Event Description
Primary procedure, left hip.It was reported that after impacting the shell, the impacting bolt was cold-welded into the shell and could not be removed.The construct was removed and another shell implanted with a screw.Surgery was completed successfully with a delay of approximately 10 minutes.
 
Manufacturer Narrative
Reported event: an event regarding disassembly issue involving a da instrument bolt was reported.The event was confirmed through visual inspection.Method & results: product evaluation and results: visual inspection of the returned device noted the following: examination of returned device indicated that the bolt was tightly fastened to the shell as described by the event details.Failure mode is confirmed.The device was separated for material analysis.Material analysis: damage consistent with the implantation/ explantation process was observed on the male threads of the impactor bolt.Hardness was performed on the flat portion of the bolt threads in accordance with astm e18.The hardness was observed to be approximately 47 hrc, meeting the drawing requirement of 40 hrc minimum.X-ray fluorescence spectroscopy energy dispersive spectroscopy showed the material is consistent with a 17-4 ph stainless steel alloy, which is consistent with the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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 operative report as well as additional information from the user are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
CUP IMPACTOR BOLT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NJ NA
IE  NA
MDR Report Key9541245
MDR Text Key185951952
Report Number0002249697-2020-00012
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327196245
UDI-Public07613327196245
Combination Product (y/n)N
PMA/PMN Number
K161569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1440-2011
Device Catalogue Number1440-2011
Device Lot NumberERDAK6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received01/02/2020
Supplement Dates Manufacturer Received03/09/2020
Supplement Dates FDA Received04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age46 YR
Patient Weight80
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