MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-32D

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916); Material Integrity Problem (2978); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported by the nurse of the hospital, that the packing of the device was damaged and therefore the device was unsterile.

Manufacturer Narrative

An event regarding outer pack damage involving a trident liner was reported.The event was confirmed.Method & results: device evaluation and results: the packaging was not returned for evaluation however an image was provide.It was confirmed from the image that a pinhole was present in the corner of the tyvek.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review found no other similar events have been reported for the subject manufacturing lot.Conclusions: the investigation concluded that the root cause of the packaging damage could not be determined based on the information provided.A review of the image was performed by the packaging cell.''all packaging operators are trained for visual inspection of packaging integrity.All packaged parts are 100% visually inspected for packaging integrity before boxing.It was concluded that the packaging associated with this event was packaged in accordance with the manufacturing and assembly procedures.Based on the information provided it was not possible to determine a root cause or when the damage occurred to the packaging.Information received indicates that the inner packaging was intact and the device was implanted.No further investigation is possible at this time.If additional information becomes available the investigation shall be reopened.

Event Description

It is reported by the nurse of the hospital, that the packing of the device was damaged and therefore the device was unsterile.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4924869
• MDR Text Key: 22505412
• Report Number: 0002249697-2015-02401
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 623-00-32D
• Device Lot Number: 50568201
• Other Device ID Number: STER. LOT 1501I301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other