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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION(TM) ADM. PRESS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION(TM) ADM. PRESS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 1235-0-008
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2017
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the restoration adm press is missing a small pin or screw that holds it together.A stryker sales rep found the green plastic end fell of the instrument.The surgeon had to improvise a way of clamping the head and mdm poly insert together using the rest of the clamp and various other pieces of generic kit.This was eventually achieved.There was a surgical delay of approximately 10 minutes.
 
Manufacturer Narrative
An event regarding a missing component involving an adm press was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection of the restoration adm press showed that the small pin is missing on the instrument.Medical records received and evaluation: no medical records were received for review by a clinical consultant.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: a review of the complaint history database shows that there has been one other event for the lot referenced.Conclusions: the subject device was determined to have been manufactured before the implementation of capa.The capa concluded that the root cause of the occurrence was due to the reamer to manufacture the pin hole was out of specification.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
The customer reported that the restoration adm press is missing a small pin or screw that holds it together.A stryker sales rep found the green plastic end fell of the instrument.The surgeon had to improvise a way of clamping the head and mdm poly insert together using the rest of the clamp and various other pieces of generic kit.This was eventually achieved.There was a surgical delay of approximately 10 minutes.
 
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Brand Name
RESTORATION(TM) ADM. PRESS
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6999462
MDR Text Key91333956
Report Number0002249697-2017-03198
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K161569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/15/2018
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 Catalogue Number1235-0-008
Device Lot NumberG3257913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/06/2017
Initial Date FDA Received11/03/2017
Supplement Dates Manufacturer Received12/18/2017
Supplement Dates FDA Received01/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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