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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 40MM; SCREW, FIXATION, BONE

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STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 40MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 2030-6540-1
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 10/26/2022
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
 
Event Description
It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.
 
Event Description
It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.Update via clinician review: [.Preoperative x-rays reveal a cementless acetabular cup with adequate fixation and possible polyethylene wear.The femoral component showed significant osteolysis with probable pathological fracture of the greater trochanter with very little cement fixation in a distal pedestal beneath the femoral implant [.].
 
Manufacturer Narrative
Correction: investigation conclusion reveals that this reported device is not a suspected cause or contributor to the patient's experience and considered concomitant.The aer decision has been updated accordingly.An event regarding osteolysis, loosening, pathological fracture of a stem involving an other hip screw was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.A clinical review of the provided medical information indicated [.] there is a cementless acetabular component in place.Position and fixation appear satisfactory [.] a full complaint investigation is completed for the stem and liner within the same pi.No further investigation is required 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
6.5 CANCELLOUS BONE SCREW 40MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
joann ripoli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15822611
MDR Text Key303901006
Report Number0002249697-2022-01656
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07613327037029
UDI-Public07613327037029
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K894124
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 02/09/2023
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 Date03/29/2020
Device Model Number2030-6540-1
Device Catalogue Number2030-6540-1
Device Lot NumberX93090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2022
Initial Date FDA Received11/18/2022
Supplement Dates Manufacturer Received01/17/2023
Supplement Dates FDA Received02/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2015
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) Hospitalization; Required Intervention;
Patient Age59 YR
Patient SexMale
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