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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 6570-0-536
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Unequal Limb Length (4534)
Event Date 10/13/2021
Event Type  Injury  
Event Description
It was reported that the patient's left hip was revised.An office note cites the following: left hip discomfort, numbness, limb length discrepancy, subluxation/ dislocation, stem subsidence.Surgeon reported that the shell was retroverted and vertical.All components were revised.Rep provided an office note and the primary operative report and confirmed that no further information will be released by the hospital or surgeon.
 
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.
 
Manufacturer Narrative
Reported event an event regarding limb length discrepancy and instability involving a 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 -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event cannot be confirmed without additional medical records.A revision surgery was proposed but not confirmed.Root cause: the root cause for the proposed revision would be as stated in the note: leg length discrepancy and hip instability.These cannot be confirmed without operative notes and addition medical records.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device 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
It was reported that the patient's left hip was revised.An office note cites the following: left hip discomfort, numbness, limb length discrepancy, subluxation/ dislocation, stem subsidence.Surgeon reported that the shell was retroverted and vertical.All components were revised.Rep provided an office note and the primary operative report and confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
DELTA V-40 CERAMIC HEAD 36/+2,5
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key12775537
MDR Text Key282770781
Report Number0002249697-2021-01858
Device Sequence Number1
Product Code JDI
UDI-Device Identifier04546540608574
UDI-Public04546540608574
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052718
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 03/27/2022
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 Model Number6570-0-536
Device Catalogue Number6570-0-536
Device Lot Number81036803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2021
Initial Date FDA Received11/08/2021
Supplement Dates Manufacturer Received02/28/2022
Supplement Dates FDA Received03/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2020
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;
Patient Age62 YR
Patient SexMale
Patient Weight75 KG
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