MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-228
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	10/31/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.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.
Event or Problem Description
Second stage revision of tritanium primary cluster cup with adm & exeter.All components revised due to instability & head/adm insert disassociation.I filed another pi on his same patient one week ago when it was discovered this patient had already been revised on the (b)(6) 2019, again due to disassociation of head with adm insert.Update (b)(6) 2019 wg: sales rep reported that the tritanium primary shell and exeter stem were also revised.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was confirmed by medical review.Method & results: device evaluation and results: the head was returned still seated within the adm liner which was still is seated within the mdm liner.The device appears unremarkable.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: the persistent instability of the right total hip arthroplasty since the original surgery for a fractured femoral neck suggests impingement at the extremes of motion and / or malposition of one or both hip components.No imaging studies available, including a lateral, can confirm the version of the components.There is no evidence this clinical situation was related to factors associated with implant design, manufacturing or materials.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including imaging studies, including a lateral, and return of the device are needed to fully investigate the event.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Second stage revision of tritanium primary cluster cup with adm & exeter.All components revised due to instability & head / adm insert disassociation.I filed another pi on his same patient one week ago when it was discovered this patient had already been revised on the (b)(6) 2019, again due to disassociation of head with adm insert.Update: sales rep reported that the tritanium primary shell and exeter stem were also revised.

• Brand Name: 28MM +4 LFIT V40 HEAD
• 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: 9383078
• Report Number: 0002249697-2019-03886
• Device Sequence Number: 2055741
• Product Code: JDI
• UDI-Device Identifier: 07613327013061
• UDI-Public: 07613327013061
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 08/31/2023
• Device Model Number: 6260-9-228
• Device Catalogue Number: 6260-9-228
• Device Lot Number: 67033407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: 68 YR