MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number 1236-2-852

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation of the adm liner from head and dislocation of the adm from the mdm liner involving an adm liner was reported.The event was confirmed by clinician review.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted that, " the undated x-rays showed pelvis/lateral hip with a stable hybrid hip and screws, an ap hip showing the same hip dislocated but the adm/mdm ball not clearly visualized.It could be attached to the 28 mm lfit ball or retained in the shell or dislodged.The pi report states that it was disassociated.The undated photos showed a shard of metal etched with #.95602 and the rim of multihole cup explant that is missing a piece of its metal rim etched with #54.The pi report notes that the lot numbers match.Adverse event identified traumatic irreducible hip dislocation, fracture of the trident shell liner and metallosis leading to revision surgery.Hazards: fracture of the trident acetabular rim, mdm/head dissociation, revision tha conclusion of assessment: review of the records confirm an irreducible exeter-mdm hip dislocation.Review of the records confirm fracture of the rim of a trident acetabular shell.Review of implant stickers could define if this was a recalled head lot.Obtaining the implant may provide additional insight into the mechanism dislocation, etiology of the rim fracture and etiology of the metallosis." device history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the patient had presented with a dislocated total hip following a fall down stairs.During the revision the shell appeared to be fractured.The available medical records were provided to the consulting clinician for a review which concluded that the undated x-rays showed pelvis/lateral hip with a stable hybrid hip and screws, an ap hip showing the same hip dislocated but the adm/mdm ball not clearly visualized.It could be attached to the 28 mm lfit ball or retained in the shell or dislodged.The pi report states that it was disassociated.The undated photos showed a shard of metal etched with #.95602 and the rim of multihole cup explant that is missing a piece of its metal rim etched with #54.The pi report notes that the lot numbers match.Review of the records confirm an irreducible exeter-mdm hip dislocation.Review of the records confirm fracture of the rim of a trident acetabular shell.Review of implant stickers could define if this was a recalled head lot.The root cause can not be determined as insufficient information was provided.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.Device not returned.

Event Description

Patient presented with dislocated left total hip replacement (exeter, trident with mdm) following fall down stairs.Hip could not be reduced as a closed reduction.When hip joint was opened, surrounding tissues was a grey/black color consistent with metallosis.28mm lfit head had disassociated from mdm head.When mdm liner was removed a small metal fragment was present in the joint.This fragment had numbers on it consistent with the lot number for implanted trident hemispherical shell.Trident shell was explanted which revealed where metal fragment had come from.Acetabulum was reamed.A titanium multihole cup was implanted with mdm liner and head.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10179518
• MDR Text Key: 201034677
• Report Number: 0002249697-2020-01252
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 1236-2-852
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 53716401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 82