MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-132
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
As per received medical records: patient was revised due to dislocation.
Additional Manufacturer Narrative
An event regarding dislocation involving a ceramic head was reported.The event was confirmed by medical review.Method & 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 concluded: "on a (b)(6) 2017 office visit the note states, ¿doing well.Incision clean, dry and intact.Staples removed.¿ on (b)(6) 2017 she was admitted for recurrent dislocation of a revision right total hip replacement.On (b)(6) 2017 a revision of the acetabular liner to a constrained liner was performed for a diagnosis of recurrent dislocation right total hip replacement.The operative report describes spinal anesthesia and use of the previous incision.During this surgery there was a change to a constrained competitor poly liner and a 28/plus-4 head, v-40, for the stryker stem.Uncomplicated surgery was described.On (b)(6) 2017 she was noted to be ¿very happydoing well wound looks great¿.No documented follow-up subsequent to this visit is available." 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 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 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.¿ also, the ceramic head was used in an off-label manner as the ifu for the ceramic head indicated, "do not substitute another manufacturer's device for any of the howmedica osteonics trident system components because design, material, or tolerance differences may lead to premature device and/or functional failure." 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.
Event or Problem Description
As per received medical records: patient was revised due to dislocation.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8198193
• Report Number: 0002249697-2018-04139
• Device Sequence Number: 16709615
• Product Code: JDI
• UDI-Device Identifier: 04546540608505
• UDI-Public: 04546540608505
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 6570-0-132
• Device Lot Number: 57446001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR