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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER CONTEMPORARY. CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH EXETER CONTEMPORARY. CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6309-4-848
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2019
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Customer reported that the implant was found to have a small piece of cardboard/paper on it when it was opened in the sterile field.*update* procedure was completed by replacing component and change of gloves.Delay of 5 minutes.Customer reported that they do not think the outer packaging box was damaged.
 
Manufacturer Narrative
An event regarding foreign matter involving exeter shell was reported.The event was confirmed following the review of the returned device.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: "visual inspection was performed.It shows damages on the box and a cardboard particle inside the inner blister.Moreover, the device has been handled: the flange has been removed.See pictures below." "by zooming in on the particle, we can see a layer of white paper on the cardboard particle, similar to the box damaged" ( reference attached supplier report) dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis not performed as this event does not relate to material integrity.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the returned device by the supplier noted "root cause the investigation concluded that the foreign body inside the inner blister seems to be a cardboard particle with a layer of white paper on the top.As there are no cardboard materials in the cleanroom #2 (iso 7), this cardboard particle could not get into the blister during the sealing process.Moreover, the device has been handled.The particle probably comes from a tearing of the damaged box, which would be introduced into the blister when unpacking the device.Corrective and preventative action no action is required at this time as there was no indication of a manufacturing issue.Lmo qa product surveillance will continue to monitor for trends." no further investigation for this event is possible at this time if additional information become available to indicate further evaluation is warranted, this record will be re-opened.
 
Event Description
Customer reported that the implant was found to have a small piece of cardboard/paper on it when it was opened in the sterile field.*update* procedure was completed by replacing component and change of gloves.Delay of 5 minutes.Customer reported that they do not think the outer packaging box was damaged.
 
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Brand Name
EXETER CONTEMPORARY. CUP
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 Key9432568
MDR Text Key186792345
Report Number0002249697-2019-03969
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6309-4-848
Device Lot NumberG7664492
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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