MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 542-11-48D

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to manufacturer.

Event Description

It was reported that surgeon revised patient's right hip due to a loose cup.Surgeon revised cup, liner head and sleeve.

Manufacturer Narrative

An event regarding shell loosening involving a trident psl ha cluster 48mm was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as the subject device was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: indicated all devices accepted into final stock met specifications.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that surgeon revised patient's right hip due to a loose cup.Surgeon revised cup, liner head and sleeve.

Event Description

It was reported that surgeon revised patient's right hip due to a loose cup.Surgeon revised cup, liner head and sleeve.

Manufacturer Narrative

An event regarding loosening involving a trident shell was reported.The event was confirmed through the medical review.Method & results: product evaluation and results: not performed as the device was not returned as it was discarded after revision surgery.Clinician review: a review of the provided medical records by a clinical consultant concluded: "discussion: [.] ¿2½-years post arthroplasty patient had a fall after which anterior hip and groin pain persisted.X-rays were described as normal.¿ [¿] a bone scan showed no obvious pathology, no evidence for loosening or infection.Cobalt and chrome levels were normal for an arthroplasty patient with 3.1-¿g/l and <1.0-¿g/l respectively.¿ [¿] ¿procedure-related factors (both pl cases): suboptimal cup position regarding inclination and anteversion patient-related factors" patient trauma as secondary trigger event high activity level as possible secondary factor but not confirmed device-related factors: -none as also supported by explant photographic findings.No formal mar available because devices were discarded after revision surgery -suboptimal cup position regarding inclination and anteversion has contributed to overload in the cup shell contributing to loss of fixation in the cup shell and consequent overload on the supplemental cup fixation screws.Osteolysis developed around the screw area causing osteolytic granuloma formation as soft tissue mass in the pelvis.During the first revision the problem was not recognised with only bearing exchange and thus the condition further deteriorated until catastrophic cup fixation failure with screw fracture only 9-months later requiring a second revision.¿ - product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that loosening was caused by the shell position.The consulting clinician indicated in the medical review, "suboptimal cup position regarding inclination and anteversion has contributed to overload in the cup shell contributing to loss of fixation in the cup shell and consequent overload on the supplemental cup fixation screws.Osteolysis developed around the screw area causing osteolytic granuloma formation as soft tissue mass in the pelvis." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT PSL HA CLUSTER 48MM
• 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 Key: 5209617
• MDR Text Key: 30689670
• Report Number: 0002249697-2015-03668
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 542-11-48D
• Device Lot Number: MKL03Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 68