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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 9 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 9 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 1601-09127
Device Problem Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2020
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Primary procedure, right hip.It was reported that when the stem was opened, it appeared to have an excessive amount of ha coating on it.A second stem was opened and used to complete the surgery successfully with no delay.The device is allegedly available for return, and the rep can provide the usage sheet from the case, but otherwise confirmed that no further information will be released.
 
Event Description
Primary procedure, right hip.It was reported that when the stem was opened, it appeared to have an excessive amount of ha coating on it.A second stem was opened and used to complete the surgery successfully with no delay.The device is allegedly available for return, and the rep can provide the usage sheet from the case, but otherwise confirmed that no further information will be released.
 
Manufacturer Narrative
Device evaluation and material analysis results reported event an event regarding appearance (excessive amount of ha coating) involving a securfit stem was reported.The event was not confirmed.Method & results -product evaluation and results: a material analysis has been performed.The color of the hydroxyapatite (ha) coating was evaluated - there was no visual evidence of a color shift.The coating appeared to be thicker around the normalizations on the anterior and posterior surfaces.The device was sectioned to evaluate the both the ha coating (d01208) and plasma sprayed porous coating (mtp113) thicknesses.The report concluded that the hydroxyapatite implant overall coating thickness was 66.30 m, which meets the 40 ¿ 70 m requirements for overall coating thickness.The local thickness measurements were between 8.023 m and 109.38 m, which is outside the range of the 30 ¿ 90 m requirements for local coating thickness and bare spots were observed on the implant surface at low magnification.The comparison against the acceptance criteria from ims0141 was done with the understanding that the ha coating had been damaged, likely from contact against a hard object.The plasma sprayed porous scaffold has a thickness requirement of 0.020 inches (+0.010/ -0.005) per the drawing.The average scaffold thickness was measured to be 0.028 with a standard deviation of 0.011 inches, the average scaffold thickness meets the drawing requirement.Medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a material analysis has been performed.The report concluded that the hydroxyapatite implant overall coating thickness was 66.30 m, which meets the 40 ¿ 70 m requirements for overall coating thickness.The local thickness measurements were between 8.023 m and 109.38 m, which is outside the range of the 30 ¿ 90 m requirements for local coating thickness and bare spots were observed on the implant surface at low magnification.The bare spots were likely caused by contact against a hard object.The comparison against the acceptance criteria from ims0141 was done with the understanding that the ha coating had been damaged, likely from contact against a hard object.The plasma sprayed porous scaffold has a thickness requirement of 0.020 inches (+0.010/ -0.005) per the drawing.The average scaffold thickness was measured to be 0.028 with a standard deviation of 0.011 inches, the average scaffold thickness meets the drawing requirement.The event and returned device were received back and visually reviewed by the members from operations, quality, materials and the complaints team.The review indicated that the local thickness did range from 8.023 m and 109 m which does not meet the 30 m - 90 m local average requirements, but individual readings within those local thicknesses are also not a basis for rejection per ims0141.In addition the damage, as described by the sem and visual analysis, is a high indicator of cause to either decrease or increase local thickness due to ha removal or ha being lifted and / or raised.The operation team review concludes that while the surgeon perceived the normalization lines to not be visible as they are accustomed to, it was confirmed through the mar, dhr review, and process review that there are proper process controls in place to determine that this product did meet all design requirements and would have functioned as intended.The reported failure mode was not confirmed as the plasma sprayed porous scaffold has a thickness requirement of 0.020 inches (+0.010/ -0.005) per the drawing.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
127 SIZE 9 SECUR-FIT ADVANCED STEM
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 Key10475776
MDR Text Key205374010
Report Number0002249697-2020-01773
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327021332
UDI-Public07613327021332
Combination Product (y/n)N
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1601-09127
Device Catalogue Number1601-09127
Device Lot NumberEX0J02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received09/01/2020
Supplement Dates Manufacturer Received11/04/2020
Supplement Dates FDA Received11/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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