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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN OMNIFIT STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN OMNIFIT STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_JR
Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)
Patient Problems Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 08/12/2020
Event Type  Injury  
Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.
 
Event Description
As reported: "omnifit stem and head revised due to osteolysis caused by competitive liner wear.Stem revised with restoration ha stem and c taper (metal) head.No further information available.Op notes and implant records are not available." spoke to rep, who confirmed date of revision and composition of the femoral head, and re-confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
An event regarding loosening involving an unknown implant stem was reported.The event was confirmed based on medical review.Method & results:  device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: "loosening of the stem can be confirmed, wear of the acetabular liner can be confirmed root cause: this is most likely the result of ¿normal¿ polyethylene wear and subsequent stem loosening.The is no obvious ¿hazard¿ related to the implant.The implant date was listed as (b)(6) 1990, if in fact the year of implant was 1990, this would be ¿expected¿ wear of the polyethylene.If confirmation was desired, one would need to obtain the implants.In addition, pathology or other laboratory data should be reviewed to rule out infectious etiology."    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: an event regarding loosening involving an unknown implant stem was reported due to osteolysis caused by competitive liner wear.The event was confirmed based on medical review.Further information such as device identification and return, pre and post operative well labelled and dated x-rays, operative reports as well as surgical pathology reports are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
As reported: "omnifit stem and head revised due to osteolysis caused by competitive liner wear.Stem revised with restoration ha stem and c taper (metal) head.No further information available.Op notes and implant records are not available." spoke to rep, who confirmed date of revision and composition of the femoral head, and re-confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
UNKNOWN OMNIFIT STEM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10501872
MDR Text Key205927509
Report Number0002249697-2020-01809
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/04/2020
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 Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/12/2020
Initial Date FDA Received09/08/2020
Supplement Dates Manufacturer Received10/09/2020
Supplement Dates FDA Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age84 YR
Patient Weight62
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