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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 42E MDM METAL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 42E MDM METAL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number UNK_SHC
Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 04/14/2022
Event Type  Injury  
Event Description
It was reported that the patient's left hip was revised due to pain.Intra-operatively, the surgeon reported that the mdm metal liner was not fully seated into the acetabular shell.An mdm metal liner, adm/ mdm poly insert, and ceramic head were revised to a poly liner with another ceramic head and sleeve.Rep reported that pictures can be provided and confirmed no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
 
Event Description
It was reported that the patient's left hip was revised due to pain.Intra-operatively, the surgeon reported that the mdm metal liner was not fully seated into the acetabular shell.An mdm metal liner, adm/ mdm poly insert, and ceramic head were revised to a poly liner with another ceramic head and sleeve.Rep reported that pictures can be provided and confirmed no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding seating/locking issue involving an unknown mdm liner was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review the information related to including the product inquiry summary and a lateral x-ray of a press fit hip.The event description from the product inquiry summary states: it was reported that the patients left hip was revised due to pain.Intra-operatively the surgeon reports that the mdm metal bearing liner was not fully seated in to the acetabular shell.The single lateral x-ray of the left hip shows a tha in satisfactory position without evidence of mechanical complication, other than the report in the product inquiry summary there is no evidence of a mechanical complication or revision surgery in the documentation provided.Should additional documentation become available i would be happy to further this assessment.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a clinician review of the provided medical records indicated: the single lateral x-ray of the left hip shows a tha in satisfactory position without evidence of mechanical complication, other than the report in the product inquiry summary there is no evidence of a mechanical complication or revision surgery in the documentation provided.The event could not be confirmed as insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
UNKNOWN 42E MDM METAL LINER
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI   NA
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14316118
MDR Text Key291231477
Report Number0002249697-2022-00651
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexFemale
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