MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-032
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
It was reported that the patient required a total hip revision surgery due to failure of the head-trunnion junction.The patient had presented to the er with dislocation of the femoral head which was confirmed upon admittance.It was further reported that the revision involved removal of the trident acetabular liner, v40 femoral head and accolade tmzf stem.The original shell was left in place.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was confirmed via evaluation of the returned devices.Method & results: product evaluation and results: visual inspection: the device was returned for evaluation.Scratches are visible on the rim of the head.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem.The head and stem were returned for evaluation.Damage consistent with the loss of taper lock was observed on the head and stem.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 revision 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient required a total hip revision surgery due to failure of the head-trunnion junction.The patient had presented to the er with dislocation of the femoral head which was confirmed upon admittance.It was further reported that the revision involved removal of the trident acetabular liner, v40 femoral head and accolade tmzf stem.The original shell was left in place.

• Brand Name: 32MM -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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16713028
• Report Number: 0002249697-2023-00374
• Device Sequence Number: 13865321
• Product Code: JDI
• UDI-Device Identifier: 07613327013009
• UDI-Public: 07613327013009
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 05/31/2012
• Device Model Number: 6260-9-032
• Device Catalogue Number: 6260-9-032
• Device Lot Number: 22717803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female