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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 502-03-52D
Device Problems Material Separation (1562); Sticking (1597); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

 
Event Description

It was reported, "inner tyvek was stuck to outer one. Inner tyvek was separated to two sheets. So, sterility was kept barely. ".

 
Manufacturer Narrative

An event regarding the tyvek lids sticking together involving a primary tritanium hemi cluster hole cup 52mm was reported. The event was confirmed. Method & results: -device evaluation and results: visual evaluation of the returned device packaging confirmed that inner blister tyvek lid was stuck to the outer lid. -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 tyvek lids sticking was caused by a known packaging issue. 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

It was reported, "inner tyvek was stuck to outer one. Inner tyvek was separated to two sheets. So, sterility was kept barely. ".

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
Type of DevicePROSTHESIS, 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 00000
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5140682
MDR Text Key28246751
Report Number0002249697-2015-03279
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device Catalogue Number502-03-52D
Device LOT NumberJA6P2X
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/22/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/09/2015 Patient Sequence Number: 1
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