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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6021-0230
Device Problems Degraded (1153); Material Deformation (2976)
Patient Problems Pain (1994); Injury (2348)
Event Date 12/17/2018
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.The other device listed in this report: cat # unknown, lot # unknown, description: unknown mitch head, manufacturer: depuy.Cat # unknown, lot # unknown, description: unknown mitch shell, manufacturer: depuy.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the patient who had been implanted with a oem accolade combination was revised.Update- the customer further reported that during x-ray of a patient in acute pain, trunnionosis or wear of the femoral head- neck interface was observed with an accolade 1 stem and oem cup.Patient reported acute increase in pain.
 
Event Description
The customer reported that the patient who had been implanted with a oem accolade combination was revised.Update- the customer further reported that during x-ray of a patient in acute pain, trunnionosis or wear of the femoral head- neck interface was observed with an accolade 1 stem and oem cup.Patient reported acute increase in pain.
 
Manufacturer Narrative
The other device listed in this report: std mitch trh cp sz 44/50; cat#mac-9988-4450; lot#fm063935 cat # unknown, lot # unknown, description: unknown mitch head, manufacturer: depuy it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A supplemental report will be submitted upon completion of the investigation.An event regarding fretting involving an accolade stem was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: a material analysis has been performed.The report concluded: damage was observed on the stem trunnion.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.Debris was also observed on the stem trunnion.Eds showed the stem was consistent with astm f1813 alloy and the debris was consistent with a corrosion product, biological material and the stem base alloy.In order to determine if any materials or manufacturing discrepancies are present on the stem, the mating mitch cup is needed for analysis.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the fretting and wear was caused by the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.Further information is needed to complete the investigation for determining root cause.
 
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Brand Name
ACCOLADE PLUS TMZF HIP STEM #2
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8245564
MDR Text Key132983925
Report Number0002249697-2019-00177
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/14/2019
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 Expiration Date02/28/2013
Device Catalogue Number6021-0230
Device Lot Number25582702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/14/2019
Supplement Dates Manufacturer Received04/16/2019
Supplement Dates FDA Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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