MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-28D

Device Problems Peeled/Delaminated (1454); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during a tha, when a nurse was peeling an outer tyvek sheet, an inner tyvek was also peeled with outer one.The pe insert was implanted without any problems.

Manufacturer Narrative

An event regarding the outer blister lid and the inner blister lid peeling off together regarding packaging of a trident liner was reported.The reported event was confirmed.Method and results: device evaluation and results: visual inspection confirmed the reported event.Medical records received and evaluation: not performed as no patient involvement was received.Device history review: review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the referenced lot.Conclusions: the opened outer blister and lid, along with the inner blister lid, was returned.The two lids were stuck together in their as returned state, and no abnormalities were noted on the surface of either lid; the event could not be confirmed nor a root cause determined.

Event Description

It was reported that, during a tha, when a nurse was peeling an outer tyvek sheet, an inner tyvek was also peeled with outer one.The pe insert was implanted without any problems.

• Brand Name: TRIDENT 0° X3 INSERT 28MM ID
• 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 NJ NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5290929
• MDR Text Key: 33875287
• Report Number: 0002249697-2015-04203
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 623-00-28D
• Device Lot Number: 2Y2T1L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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