MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +12 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6260-9-432
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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 and metallosis.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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised.As reported: "the patient reported pain and discomfort in her left hip, x-rays showed a size 1 accolade tmzf stem with a 32+12 v40 femoral head disassociated from the trunnion, she was brought to the operating room for a revision surgery, the femoral head was found to be disassociated from the stem, there was damage to some of the soft tissues and metallosis findings, a femoral revision was performed utilizing another company¿s implant, the acetabular component was stryker and was retained, a liner exchange was performed on the trident acetabular cup, it was a size d alpha code.No further information is available or implants due to facility policy.Rep confirmed there were no allegations against the revised liner.
Additional 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.H3 other text : device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised.As reported: "the patient reported pain and discomfort in her left hip, x-rays showed a size 1 accolade tmzf stem with a 32+12 v40 femoral head disassociated from the trunnion, she was brought to the operating room for a revision surgery, the femoral head was found to be disassociated from the stem, there was damage to some of the soft tissues and metallosis findings, a femoral revision was performed utilizing another company¿s implant, the acetabular component was stryker and was retained, a liner exchange was performed on the trident acetabular cup, it was a size d alpha code.No further information is available or implants due to facility policy.Rep confirmed there were no allegations against the revised liner.

• Brand Name: 32MM +12 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18934728
• Report Number: 0002249697-2024-00448
• Device Sequence Number: 7027427
• Product Code: LPH
• UDI-Device Identifier: 07613327013153
• UDI-Public: 07613327013153
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 11/30/2011
• Device Catalogue Number: 6260-9-432
• Device Lot Number: 20566701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2006
• 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