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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Model Number 626-00-46F
Device Problem Device Damaged by Another Device (2915)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 01/15/2020
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.Not returned.
 
Event Description
It was reported that the patient's left hip was revised due to severe notching of the neck of the stem, leading to surgeon's concern that the neck of the stem may break off.Surgeon reported the reason for notching was due to impingement with the mdm metal liner, not the shell.Intra-operatively, a significant amount of metallosis was noted in the patient's soft tissue.The patient's entire hip construct was revised to a restoration modular stem construct, trident ii shell, poly liner and femoral head.Rep confirmed there are no allegations against the revised adm/ mdm poly insert or the femoral head.
 
Manufacturer Narrative
Reported event: an event regarding metallosis involving a mdm liner was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned.Visual inspection of the received image of the explant noted nothing noteworthy.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were available for a review with the clinician.Device history review: could not be performed as the device lot code was not provided.Complaint history review: could not be performed as the device lot code was not provided.Conclusion: it was reported that the patient was revised due to notching of the stem neck.Intra-operatively, a significant amount of metallosis was noted in the patient's soft tissue.The device was not returned.Visual inspection of the received image of the explant noted nothing noteworthy.The event could not be confirmed nor the exact cause of the event be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.H3 other text : device not returned.
 
Event Description
It was reported that the patient's left hip was revised due to severe notching of the neck of the stem, leading to surgeon's concern that the neck of the stem may break off.Surgeon reported the reason for notching was due to impingement with the mdm metal liner, not the shell.Intra-operatively, a significant amount of metallosis was noted in the patient's soft tissue.The patient's entire hip construct was revised to a restoration modular stem construct, trident ii shell, poly liner and femoral head.Rep confirmed there are no allegations against the revised adm/ mdm poly insert or the femoral head.
 
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Brand Name
MODULAR DUAL MOBILITY INSERT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9702660
MDR Text Key188714099
Report Number0002249697-2020-00281
Device Sequence Number1
Product Code LZO
UDI-Device Identifier04546540666024
UDI-Public04546540666024
Combination Product (y/n)N
PMA/PMN Number
K103233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/26/2020
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 Model Number626-00-46F
Device Catalogue Number626-00-46F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2020
Initial Date FDA Received02/12/2020
Supplement Dates Manufacturer Received02/27/2020
Supplement Dates FDA Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
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