MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 52MM; IMPLANT

Catalog Number 542-11-52E

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 12/02/2013

Event Type  Injury  

Event Description

It was reported that the patient suffered a dislocation of a left hip constrained liner.The acetabular component was revised.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown liner.An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Additional information (including x-rays and medical records) has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding dislocation involving a trident psl ha cluster 50mm and a citation tmzf ha stem #3 right (cat # 6265-5113 lot # 42645801 description: citation tmzf ha stem #3 right) was reported.The event was confirmed.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated that the root cause of the dislocation was a malpositioned shell.Furthermore the implantation of a right femoral stem in a left hip may have led to instability contributing to the dislocation.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the investigation concluded that the dislocation was caused by a malpositioned acetabular shell in tandem with an incorrect side femoral stem.There is no indication that the reported event was device related.

Event Description

It was reported that the patient suffered a dislocation of a left hip constrained liner.The acetabular component was revised.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿principal root cause of failure was cup malposition leading to impingement and recurrent dislocation.The first revision with exchange of the regular trident liner to a constrained liner only made things worse due to the reduced rom effects of such constrained liners while the second revision did a better job by addressing the underlying cup malposition problem.Because cup position was the principal problem and the surgeon is responsible for optimal component placement, principal root cause of failure is procedure-related with the instability further aggravated by another procedure-related effect related to early postoperative muscular laxity as caused by the previous arthroplasty procedure and an additional patient-related factor of muscular atrophy due to high patient age.This failure scenario applies to the first revision (pi) but because the root cause of failure was not addressed during the first revision, a second revision surgery became necessary (pi) also the second revision has exactly the same root cause of failure relating to persistence of present underlying instability factors including cup malposition.No indications for presence of device-related factors were seen and as such root cause of failure for both listed pi cases is not device-related.A review of the provided medical records by a clinical consultant indicated that the root cause of the dislocation was a malpositioned shell.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the patient suffered a dislocation of a left hip constrained liner.The acetabular component was revised.

• Brand Name: TRIDENT PSL HA CLUSTER 52MM
• 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 Key: 3603860
• MDR Text Key: 19919519
• Report Number: 0002249697-2014-00258
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 542-11-52E
• Device Lot Number: MMJ691
• Other Device ID Number: STERILE LOT: MSHLR16A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• 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): Required Intervention
• Patient Age: 52 YR