MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN X3P POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/30/2012

Event Type  Injury  

Manufacturer Narrative

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.Device not available.

Event Description

As per received medical records: "closed reduction, right total hip replacement, (b)(6) 2012.[.] the (b)(6) 2012 dislocation was laying in a rocker recliner and probably internally rotating by moving her pelvis over the hip in external rotation.".

Event Description

As per received medical records: "closed reduction, right total hip replacement, (b)(6) 2012.The (b)(6) 2012 dislocation was laying in a rocker recliner and probably internally rotating by moving her pelvis over the hip in external rotation.".

Manufacturer Narrative

Corrected data: b2 - outcomes attributed to ae an event regarding dislocation involving an unknown liner was reported.The event was confirmed by medical review.Methods & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant revealed: ¿on (b)(6) 2012 a posterior dislocation of the right hip occurred for which a closed reduction and an application of an abduction splint were noted.On (b)(6) 2013 she was described as wearing the splint, and on (b)(6) 2013, (b)(6) 2013 and (b)(6) 2013 she was noted to be unchanged with ¿excellent x-ray¿.Visits of (b)(6) 2014 and (b)(6) 2014 noted her to be ¿doing better¿."no examination of any explanted components is available.This entire complex clinical picture relates to the sequelae of a mrsa periprosthetic infection originally diagnosed six months status-post primary total hip and treated conservatively for nine years until implant removal and antibiotic spacer was implanted.Previous and subsequent dislocations were related to persistent sepsis and revision surgery.There is no evidence that factors associated with any stryker implant design, manufacturing or materials contributed to this complex clinical history.¿ product history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the investigation confirmed the reported event of dislocation and the root cause was noted to be due to the patients infection.The clinician noted in the medical review that the dislocations are related to persistent sepsis and ¿there is no evidence that factors associated with any stryker implant design, manufacturing or materials contributed to this complex clinical history.¿ 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: UNKNOWN X3P POLY LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8198125
• MDR Text Key: 131470392
• Report Number: 0002249697-2018-04134
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR