Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 542-11-58G
Device Problems Crack (1135); Fracture (1260)
Patient Problems Injury (2348); Reaction (2414); Device Embedded In Tissue or Plaque (3165)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's right hip was revised after patient complaint of pain.Intra- operatively, black tissue and ceramic fragments were noted, and no ceramic was inside of the alumina insert.The shell, 2 screws, alumina liner and alumina head were revised.Rep provided a primary operative report and implant sheet, pre-revision x-rays, and explant pictures.
 
Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident shell reported.Conclusions: it was reported that patient was revised due to pain.The review of the provided medical records by clinical consultant state that: the x-rays include an ap and lateral the right hip.They demonstrate an uncemented right tha with 2 screws in the acetabular shell, with the acetabular and femoral components well fixed and nominally positioned.An alumina head is reduced into the acetabular component but is eccentrically migrated superiorly and several radio-dense fragments are noted adjacent to the joint.This is consistent with the description of a fragmented, alumina, acetabular insert".Need revision operative reports, office/clinical reports, serial x-rays, etc.Based on the provided information the product reported in this investigation did not contribute to the event and is therefore considered concomitant.As this case refer to crack/fracture between liner and head so shell not contributed to failure.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the patient's right hip was revised after patient complaint of pain.Intra- operatively, black tissue and ceramic fragments were noted, and no ceramic was inside of the alumina insert.The shell, 2 screws, alumina liner and alumina head were revised.Rep provided a primary operative report and implant sheet, pre-revision x-rays, and explant pictures.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIDENT PSL HA CLUSTER 58MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8727913
MDR Text Key148979500
Report Number0002249697-2019-02355
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327037319
UDI-Public07613327037319
Combination Product (y/n)N
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2009
Device Catalogue Number542-11-58G
Device Lot Number17147801
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
-
-