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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 44MM CERAMIC HEAD; HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 44MM CERAMIC HEAD; HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Scratched Material (3020)
Patient Problem Injury (2348)
Event Date 06/03/2011
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
This pi is for the revision of primary on (b)(6) 2011.As reported: "the doctor revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown, however a revision surgery was done on (b)(6) 2011 to address a loose cup." spoke to rep regarding the (b)(6) revision.Patient has had a stryker stem since the prior implantation and rep is very certain the revised construct consisted of stryker devices.The rep and surgeon cannot confirm this as records prior to the 2011 revision do not exist, but based on the existence of the stryker stem (and head, which had been revised in 2011), both rep and surgeon have high confidence there was a revision of stryker devices.A 56mm shell, 2 fractured screws, liner, and morse taper ceramic head were revised to a 60mm shell with 3 screws, c-taper adapter sleeve, and 44mm biolox ceramic head with a 44f x3 0° liner.The stem was not revised.Rep does not have access to any additional information from the hospital or surgeon.
 
Manufacturer Narrative
An event regarding wear involving a unknown ceramic head was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: the patient underwent a primary left total hip arthroplasty for which no date of surgery, no operative report and no list of components are available.On june 2, 2011 he underwent a left hip revision with bone grafting of the acetabulum for a diagnosis of ¿failed left tha¿.The operative report describes spinal anesthesia and a posterolateral approach.The report notes, ¿ceramic head removed ¿ cup removed easily with kocher ¿ had two fractured screws ¿ not visualized ¿ had 56 cup ¿ reamed to 58 for 60 trident tritanium cup with three screws.A 44/0° x3 liner ¿ universal/c-taper 0 adapter sleeve and a 44 biolox ceramic head, universal, were implanted by uncomplicated surgery.¿ the patient was subsequently discharged on june 6, 2011.No patient demographics, no clinical or past medical history, no primary left total hip arthroplasty date or operative report, or examination of explanted components or serial x-rays are available.Based upon the information available for review, it is not possible to confirm the alleged loosening of the primary acetabulum, which was revised on june 3, 2011 or speculate as to the cause.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as patient demographics, clinical and past medical history, primary left total hip arthroplasty date, operative report, examination of explanted components and serial x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
This pi is for the revision of primary on (b)(6) 2011.As reported: "the doctor revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown, however a revision surgery was done on (b)(6) 2011 to address a loose cup." spoke to rep regarding the june 3 revision.Patient has had a stryker stem since the prior implantation and rep is very certain the revised construct consisted of stryker devices.The rep and surgeon cannot confirm this as records prior to the 2011 revision do not exist, but based on the existence of the stryker stem (and head, which had been revised in 2011), both rep and surgeon have high confidence there was a revision of stryker devices.A 56mm shell, 2 fractured screws, liner, and morse taper ceramic head were revised to a 60mm shell with 3 screws, c-taper adapter sleeve, and 44mm biolox ceramic head with a 44f x3 0° liner.The stem was not revised.Rep does not have access to any additional information from the hospital or surgeon.
 
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Brand Name
UNKNOWN 44MM CERAMIC HEAD
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8333735
MDR Text Key135992102
Report Number0002249697-2019-01025
Device Sequence Number1
Product Code LZO
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 04/22/2019
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_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/16/2019
Initial Date FDA Received02/12/2019
Supplement Dates Manufacturer Received03/25/2019
Supplement Dates FDA Received04/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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