MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-322
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient's hip was revised due to disassociation.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A third revision of this patient that is mentally and physically challenged, as it has dislocated again using an exeter stem and head.Update 16 june 2021: rep confirmed that this was the patients 2nd revision, but third case.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a metal head was reported.The event was not confirmed.Method & results.Product evaluation and results: visual inspection, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review:  no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.  conclusion: based on the provided information it has been determined that this event is associated with an off label application.The patient was first revised due to dislocation and during the surgery, off-label usage was identified.The reported second revision of this patient was mentally and physically challenged, as it has dislocated again using an exeter stem and head.The surgeon had to use a +8mm head which is off label use on the 33mm exeter stem and the 33mm exeter stem was used when revised and the cup (a competitor) was re implanted.The event of dislocation was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A third revision of this patient that is mentally and physically challenged, as it has dislocated again using an exeter stem and head.Update 16 june 2021: rep confirmed that this was the patients 2nd revision, but third case.

• Brand Name: 22.2MM +8 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: 12125689
• Report Number: 0002249697-2021-01143
• Device Sequence Number: 20037979
• Product Code: JDI
• UDI-Device Identifier: 07613327013092
• UDI-Public: 07613327013092
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 11/30/2025
• Device Model Number: 6260-9-322
• Device Catalogue Number: 6260-9-322
• Device Lot Number: 81235708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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: 39 YR