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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; IMPLANT Back to Search Results
Catalog Number 542-11-54F
Device Problems Disassembly (1168); Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 01/15/2014
Event Type  Injury  
Event Description
The patient was being revised as the poly disassociated from the cup.The original surgical plan was a poly exchange however, the surgeon tired two new poly liners that would not lock into the existing shell, so the shell and head were also replaced.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
An event regarding a dissociated liner from shell and the inability to insert two liners into a shell involving a trident psl ha cluster 54mm was reported.The dissociation was confirmed; the inability to insert the two liners into the shell was not confirmed.A material analysis confirmed no material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: ¿a review of the x-rays noted the insert was out of the shell with the head articulating with the empty shell¿the early disassociation of the poly insert suggests failure to adequately lock it in place at the primary surgery, possibly due to poor exposure or soft tissue interposition.There is no evidence of faulty component manufacturing or material being responsible for this clinical situation.¿ a device history review confirmed all devices were manufactured and accepted into finished goods with no reported discrepancies.A complaint history review confirmed no similar events for the reported lot.The investigation concluded that the dissociation of the liner from the shell was likely caused by surgeon error.According to a review of the provided medical records by a clinical consultant, ¿the early disassociation of the poly insert suggests failure to adequately lock it in place at the primary surgery, possibly due to poor exposure or soft tissue interposition.There is no evidence of faulty component manufacturing or material being responsible for this clinical situation.¿ surgical protocol, lsp68 version 1, includes specific instructions on how to successfully implant the liner into the shell.It was also reported that the surgeon was unable to insert two liners into the shell.Despite this complaint, the shell was returned with one of the reported liners fully captured and thus, this failure mode could not be confirmed.
 
Event Description
The patient was being revised as the poly disassociated from the cup.The original surgical plan was a poly exchange however, the surgeon tired two new poly liners that would not lock into the existing shell, so the shell and head were also replaced.
 
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Brand Name
TRIDENT PSL HA CLUSTER 54MM
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3623142
MDR Text Key17276135
Report Number0002249697-2014-00362
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue Number542-11-54F
Device Lot NumberMMJ34M
Other Device ID NumberSTERILE LOT# MSHMJ17A3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2013
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) Required Intervention;
Patient Age71 YR
Patient Weight113
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