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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number 1236-2-848
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)
Event Date 10/16/2020
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.
 
Event Description
The initial tha was performed in 2018, the installation angle of the cup was very good but mdm dislocation was diagnosed.Initially, it was expected that the patient's pelvic tilt would progress which caused dislocation, but the head and polyethylene had already dissected in the body already.Since the color of the head has changed, the metal liner and polyethylene were not moved smoothly, and it was thought that the head and cup may have been impinged and dislocated.The polyethylene has already damaged it when it was removed, there is scratches now and the slip is not very good.After putting the head in polyethylene, the sr is planned to check if it turns smoothly.The sliding surface between the metal liner and polyethylene cannot be confirmed, but it is suspected that this was the cause.
 
Event Description
The initial tha was performed in 2018, the installation angle of the cup was very good but mdm dislocation was diagnosed.Initially, it was expected that the patient's pelvic tilt would progress which caused dislocation, but the head and polyethylene had already dissected in the body already.Since the color of the head has changed, the metal liner and polyethylene were not moved smoothly, and it was thought that the head and cup may have been impinged and dislocated.The polyethylene has already damaged it when it was removed, there is scratches now and the slip is not very good.After putting the head in polyethylene, the sr is planned to check if it turns smoothly.The sliding surface between the metal liner and polyethylene cannot be confirmed, but it is suspected that this was the cause.
 
Manufacturer Narrative
Reported event: an event regarding dislocation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicates that explantation damages as well as surface scratches were observed.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
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Brand Name
RESTORATION ADM X3 INS 28/48
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10819677
MDR Text Key215617279
Report Number0002249697-2020-02406
Device Sequence Number1
Product Code MEH
UDI-Device Identifier04546540638977
UDI-Public04546540638977
Combination Product (y/n)N
PMA/PMN Number
K093644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number62917201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age82 YR
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