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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 1236-2-854
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Loss of Range of Motion (2032); Joint Dislocation (2374)
Event Date 10/13/2020
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.If additional information is received, 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 dissociation of the ceramic femoral head from the adm/mdm poly insert.The ceramic head, poly insert, and mdm metal liner were revised.Rep can provide pictures and the devices are allegedly available for return.Rep confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding disassociation involving a adm liner was reported.The event was confirmed via medical review.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device was returned in used condition.Device had signs of wear throughout and damage consistent with explantation.Clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: the dissociation of the ceramic head from the polyethylene ball can be confirmed.The head is eccentric in the shell.Product history review: all 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: a review of the provided medical information by a clinical consultant indicated: confirmation: the dissociation of the ceramic head from the polyethylene ball can be confirmed.The head is eccentric in the shell.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the patient's left hip was revised due to dissociation of the ceramic femoral head from the adm/ mdm poly insert.The ceramic head, poly insert, and mdm metal liner were revised.Rep can provide pictures and the devices are allegedly available for return.Rep confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
RESTORATION ADM X3 INS 28/54
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
MDR Report Key10800229
MDR Text Key215012661
Report Number0002249697-2020-02357
Device Sequence Number1
Product Code MEH
UDI-Device Identifier04546540639004
UDI-Public04546540639004
Combination Product (y/n)N
PMA/PMN Number
K093644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2008
Device Model Number1236-2-854
Device Catalogue Number1236-2-854
Device Lot Number37053601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Initial Date Manufacturer Received 10/13/2020
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer Received12/02/2020
Supplement Dates FDA Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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