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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 0580-1-443
Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Device Issue (2379); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 03/01/2016
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
 
Event Description
The customer reported that the spigot protector on the exeter 44 no 3 is too thick to fit the instrumentation.The device was inserted by hand.No time delay, but surgical flow disrupted and an alteration to surgical technique due to being unable to attach the implant to the implant introducer.
 
Manufacturer Narrative
An event regarding a damaged spigot protector involving an exeter stem was reported.The event was confirmed.The returned spigot show 2 bent lugs: lugs are still parallel but they are not perpendicular to the body of the spigot.The lugs are bent outwards the investigation concluded that the root cause of this event was due to a manufacturing issue with the spigot supplier to lisi.The supplier investigation determined the device escaped inspection.
 
Event Description
The customer reported that the spigot protector on the exeter 44 no 3 is too thick to fit the instrumentation.The device was inserted by hand.No time delay, but surgical flow disrupted and an alteration to surgical technique due to being unable to attach the implant to the implant introducer.
 
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Brand Name
EXETER V40 STEM 44MM NO 3
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5538786
MDR Text Key41778162
Report Number0002249697-2016-01026
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0580-1-443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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