Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 8 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 8 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 1601-08127
Device Problems Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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 as the secur-fit advanced stem was being implanted and was about 1/2 way up the ha coating, the pa observed the stem looked unusual.The stem was removed and inspected.The ha coating seemed to be much thicker than normal, with the normalization lines on the sides nearly filled in.Another stem (same catalog, different lot) was opened and looked completely different than the first stem, and looked normal.There was an approximate 5 minute surgical delay to retrieve the second stem.Rep was present for the procedure and witnessed the stem.Rep provided the usage sheet showing the wasted stem, and pictures of the device, which is available for return.
 
Manufacturer Narrative
H1 reported as serious injury in error and corrected to malfunction.Reported event an event regarding other involving a secure-fit stem was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection of the returned device noted the following: device was returned in unused condition.The ha coating appeared thicker than usual.No other remarkable observations were noted.Dimensional inspection of the returned device noted the following: dimensional analysis was completed by a manufacturing sme.See below for more details.-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: an investigation on this product was initiated after operations was made aware of this complaint.The investigation included a visual re-inspection.The ha spray on product was initially inspected, per the normal process requirements.Following the ha spray inspection, the ha was stripped per procedure, and then the plasma spray was inspected.Both inspections were conducted by trained inspectors who passed the product again for visual requirements.Due to this product passing both the original inspection and the re-inspection, the complaint record shall not escalate to the initiation of a non-conformance record.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.
 
Event Description
Primary procedure, right hip.It was reported that as the secur-fit advanced stem was being implanted and was about 1/2 way up the ha coating, the pa observed the stem looked unusual.The stem was removed and inspected.The ha coating seemed to be much thicker than normal, with the normalization lines on the sides nearly filled in.Another stem (same catalog, different lot) was opened and looked completely different than the first stem, and looked normal.There was an approximate 5 minute surgical delay to retrieve the second stem.Rep was present for the procedure and witnessed the stem.Rep provided the usage sheet showing the wasted stem, and pictures of the device, which is available for return.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
127 SIZE 8 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 Key9214839
MDR Text Key163173739
Report Number0002249697-2019-03566
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327021318
UDI-Public07613327021318
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,other
Type of Report Initial,Followup
Report Date 03/24/2020
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 Expiration Date04/30/2024
Device Model Number1601-08127
Device Catalogue Number1601-08127
Device Lot Number316WH3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2019
Initial Date Manufacturer Received 09/23/2019
Initial Date FDA Received10/21/2019
Supplement Dates Manufacturer Received02/25/2020
Supplement Dates FDA Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
-
-