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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 7236-2-848
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 07/14/2023
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.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.H3 other text : device not returned to the manufacturer.
 
Event Description
It was reported that the patient's left hip was revised.Patient presented to the er with a dislocation.A closed reduction was attempted and was unsuccessful.During the revision, the poly insert was found to have dissociated from the femoral head and dislocated from the metal liner.The poly insert, femoral head and stem were revised (stem was revised to add version to the hip construct).The metal liner and shell were retained.
 
Event Description
It was reported that the patient's left hip was revised.Patient presented to the er with a dislocation.A closed reduction was attempted and was unsuccessful.During the revision, the poly insert was found to have dissociated from the femoral head and dislocated from the metal liner.The poly insert, femoral head and stem were revised (stem was revised to add version to the hip construct).The metal liner and shell were retained.
 
Manufacturer Narrative
An event regarding disassociation and dislocation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the rim of the inner diameter of the liner is slightly deformed.Minor scratches are observed in the inner diameter.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or the explantation attempt.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to disassociation of the ceramic head from the adm poly liner and dislocation of the adm poly liner from the mdm metal liner.Visual inspection of the returned devices indicated that the head and liner were damaged from the disassociation/dislocation event as well as explantation.Further information such as pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.It was reported that the stem was also revised to add version to the hip construct; it is likely that the choice of stem implant contributed to the construct failure 3 days post-operative.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
RESTORATION ADM X3 INS 28/48
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
joann ripoli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17439748
MDR Text Key320207667
Report Number0002249697-2023-00870
Device Sequence Number1
Product Code MEH
UDI-Device Identifier07613327315974
UDI-Public07613327315974
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7236-2-848
Device Lot Number98689401
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2023
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;
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