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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 52MM INSERT; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 52MM INSERT; HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Detachment Of Device Component (1104)
Patient Problem Injury (2348)
Event Date 05/15/2008
Event Type  Injury  
Manufacturer Narrative
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
During review of surgery records, it was noted that a intraoperative complication was reported during primary arthroplasty in 2008.As reported in the surgical records, the retention wire of the insert came off during implantation of same and required intraoperative cup removal with another try using the same cup but a new insert.The 2008 record stated "while impacting the insert, the spring ring dislocates, thus the insert has to be removed.Since it is firmly seated, this can only be removed by leveraging out the entire cup.A new insert must be obtained.While waiting, the wound is sterilely covered; afterwards, reaming with size 52 is performed again.Given the existing protrusion.The depth cortical bone attached down to the floor.Next, the cup is re-inserted.".
 
Manufacturer Narrative
Corrected data: adverse event/product problem; outcomes attributed to ae.Additional information: patient identifier, date of birth; gender.An event regarding damage involving an unknown liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-medical records received and evaluation: not performed as no medical information was provided.-device history review: not performed as lot information was not provided.-complaint history review: not performed as lot information was not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as product details, product evaluation, product return and/or pictures are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
During review of surgery records, it was noted that a intraoperative complication was reported during primary arthroplasty in 2008.As reported in the surgical records, the retention wire of the insert came off during implantation of same and required intraoperative cup removal with another try using the same cup but a new insert.The 2008 record stated "while impacting the insert, the spring ring dislocates, thus the insert has to be removed.Since it is firmly seated, this can only be removed by leveraging out the entire cup.A new insert must be obtained.While waiting, the wound is sterilely covered; afterwards, reaming with size 52 is performed again.Given the existing protrusion.The depth cortical bone attached down to the floor.Next, the cup is re-inserted.".
 
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Brand Name
UNKNOWN 52MM INSERT
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7132510
MDR Text Key95318390
Report Number0002249697-2017-03643
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age56 YR
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