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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Model Number 6052-0935S
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
An event regarding neck damage involving a securefit stem was reported.The event of neck damage was confirmed by inspection of the received image of the device and event of metalosis could not be confirmed.Method & results: device evaluation and results: the device was not returned.Visual inspection of the received image of the explant noted the neck to be damaged.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 the neck to be damaged.The exact cause of the event could not be determined because insufficient information was provided.The event of metalosis could not be confirmed.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.
 
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
SECUR-FIT MAX 127 HIP STEM #9
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 Key9702658
MDR Text Key188715194
Report Number0002249697-2020-00282
Device Sequence Number1
Product Code LZO
UDI-Device Identifier07613327021127
UDI-Public07613327021127
Combination Product (y/n)N
PMA/PMN Number
K051738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number6052-0935S
Device Catalogue Number6052-0935S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2020
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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