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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM; IMPLANT Back to Search Results
Catalog Number 500-03-58F
Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)
Patient Problem No Information (3190)
Event Date 06/13/2014
Event Type  Injury  
Event Description
Product packaging was compromised.Top of implant packaging was stuck to under side of implant packaging wrap and caused implant sterility to be compromised.We had a backup product of same size and functionality so we were okay and just used the backup.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding the foam packaging being stuck to the inner blister tyvek lid involving a primary tritanium hemi solidback cup 58mm was reported.The event was confirmed.Method and results: device evaluation and results: visual evaluation of the returned device packaging confirmed that inner blister tyvek lid was attached to the top layer of packaging foam from the void-filling and heat sealing process.Medical records received and evaluation: not performed as no patient information was provided for review.Device history review: a device history review indicated that all devices that were accepted into final stock conformed to specification.Complaint history review: a complaint history review indicated that there have been no similar events for the reported lot.Conclusions: the investigation concluded that foam packaging being stuck to the inner blister (b)(6) lid of a primary tritanium hemi solidback cup 58mm was caused by a known packaging issue.The raised foam during the sealing operation allowed for excessive contact of the sealing tool with the inner lidstock and packaging foam resulting in sealing or melting of the lidstock to the foam.It is related to a void-filling approach to sterile product packaging.Packaging innovation is aware of this, and has issued a memo.Due to the infrequent nature of these complaints and the greater risk that would be presented by an undersized foam, these events will not be addressed through a design change.
 
Event Description
Product packaging was compromised.Top of implant packaging was stuck to under side of implant packaging wrap and caused implant sterility to be compromised.We had a backup product of same size and functionality so we were okay and just used the backup.
 
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Brand Name
PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3925584
MDR Text Key4496361
Report Number0002249697-2014-02600
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2014
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 Date03/31/2019
Device Catalogue Number500-03-58F
Device Lot NumberMNE5JP
Other Device ID NumberSTERILE LOT MSHNE31A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/13/2014
Initial Date FDA Received07/10/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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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