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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CERAMIC LEFT HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CERAMIC LEFT HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_JR
Device Problem Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2023
Event Type  Injury  
Event Description
Patient stated he is experiencing audible popping and squeaking to the left hip.States the symptoms have gotten progressively worse over the years.Initially it was a single pop but now experiences multiple pops in a row when attempting to stand up right.Claims it is a trident ceramic hip with a surgical date of (b)(6) 2004.Patent denies pain.
 
Manufacturer Narrative
Reported event: an event regarding audible noise involving an unknown hip implant 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 remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient experiencing audible popping and squeaking to the left hip.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
 
Event Description
Patient stated he is experiencing audible popping and squeaking to the left hip.States the symptoms have gotten progressively worse over the years.Initially it was a single pop but now experiences multiple pops in a row when attempting to stand up right.Claims it is a trident ceramic hip with a surgical date of (b)(6) 2004.Patent denies pain.
 
Manufacturer Narrative
Correction: this mdr report is being closed as a duplicate of fda mfr reference 0002249697-2019-03955.
 
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Brand Name
UNKNOWN TRIDENT CERAMIC LEFT HIP
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key16910564
MDR Text Key314986935
Report Number0002249697-2023-00502
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/05/2023
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 Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/19/2023
Initial Date FDA Received05/11/2023
Supplement Dates Manufacturer Received07/05/2023
Supplement Dates FDA Received07/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age69 YR
Patient SexMale
Patient Weight127 KG
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