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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 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 502-03-56E
Device Problems Material Discolored (1170); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2015
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The nurse went to open the implant some discoloring was noticed. While trying to open the implant, the outer packaging was stuck to the inner packaging. The surgeon asked for a replacement implant. There was no adverse consequences or delay of surgery.

 
Manufacturer Narrative

An event regarding a packaging issue involving a tritanium shell was reported. The event was confirmed. Method & results: -device evaluation and results: the outer blister was not stuck to the inner blister. The foam was stuck to the inner tyvek lid. -medical records received and evaluation: the event is not related to patient factors. -device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other events for this lot. Conclusions: the investigation concluded that the outer blister was not stuck to the inner blister. It is likely that it got unstuck when it was peeled back. However, the foam was stuck to the inner tyvek lid. This is a known packaging issue. Packaging innovations is aware of this, and has issued a memo. The device¿s sterile barrier was not been compromised.

 
Event Description

The nurse went to open the implant some discoloring was noticed. While trying to open the implant, the outer packaging was stuck to the inner packaging. The surgeon asked for a replacement implant. There was no adverse consequences or delay of surgery.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5042313
MDR Text Key24611644
Report Number0002249697-2015-02889
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
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 08/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device Catalogue Number502-03-56E
Device LOT NumberTR7JYL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2015
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: 08/31/2015 Patient Sequence Number: 1
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