MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-332
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
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.Device not available.
Event or Problem Description
It was reported the patient's hip was revised due to the trunnion breaking off the stem.A citation stem, v40 36 head, and 0° g liner were revised to a competitor stem and head with a stryker liner.
Additional Manufacturer Narrative
An event regarding crack/fracture of a citation stem involving an unknown metal head was reported.Conclusion: a full investigation was completed for the stem within this pi.During revision surgery, the head, which is taper locked onto the stem had to be removed as the stem was being explanted.Based on the information provided there is no indication or allegation that device reported in this investigation may have contributed to 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
It was reported the patient's hip was revised due to the trunnion breaking off the stem.A citation stem, v40 36 head, and 0° g liner were revised to a competitor stem and head with a stryker liner.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed through evaluation of the returned device and clinician review of the provided medical records.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report (mar).This inspection indicated: stereo microscope imaging of the v40 head showed discolouration and material loss within the head taper.A material analysis has been performed.The report concluded: review of the citation tmzf ha stem, catalogue # 6265-5106, lot code 20540502, v40 head, catalogue # 6260-9-332, lot code 17794302 and poly liner was completed using visual examination, stereo microscopy examination and scanning electron microscopy examination.The citation stem was confirmed to have fractured through the neck region.In addition, damage to the stem trunnion and head taper was observed, with damage and discolouration of the poly liner also observed.The damage to the stem trunnion and head taper was consistent with wear, potentially related to the head taper and stem trunnion losing taper lock.The damage on the poly liner was consistent with contact with the citation stem.Clinician review a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms trunnion fracture, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components.Device 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 reported lot.Conclusion: visual inspection was performed as part of the material analysis report (mar).This inspection indicated: stereo microscope imaging of the v40 head showed discolouration and material loss within the head taper.A material analysis has been performed.The report concluded: review of the citation tmzf ha stem, catalogue # 6265-5106, lot code 20540502, v40 head, catalogue # 6260-9-332, lot code 17794302 and poly liner was completed using visual examination, stereo microscopy examination and scanning electron microscopy examination.The citation stem was confirmed to have fractured through the neck region.In addition, damage to the stem trunnion and head taper was observed, with damage and discolouration of the poly liner also observed.The damage to the stem trunnion and head taper was consistent with wear, potentially related to the head taper and stem trunnion losing taper lock.The damage on the poly liner was consistent with contact with the citation stem.A review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms trunnion fracture, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported the patient's hip was revised due to the trunnion breaking off the stem.A citation stem, v40 36 head, and 0° g liner were revised to a competitor stem and head with a stryker liner.

• Brand Name: 32MM +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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 8887649
• Report Number: 0002249697-2019-02820
• Device Sequence Number: 11409790
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2023

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: 03/31/2011
• Device Model Number: 6260-9-332
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 17794302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/10/2019; 01/19/2023
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/08/2019; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG