MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0537
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	12/29/2023
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.
Event or Problem Description
Patient presented with right hip pain on 29/12/23 and had x-ray.Referred to orthopedics.Attended orthopedic outpatients the next day (was able to walk in) x-ray showed head appeared to have disassociated from trunnion.Past history of a fall approximately 12 months ago.Revision right total hip replacement done today (b)(6) 2024.Accolade tmzf stem, v40 lfit 36mm head and trident insert removed.New trident x3 insert implanted with competitor distal fitting stem.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem 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.Damages an scratches are visible along the body of the stem, damage/wear is visible on the stem trunnion.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: a review of medical records with a clinical consultant indicated the photograph of the femoral head and stem demonstrates dissociation of the head from the stem.The trunnion of the stem is remodeled with significant material loss on the distal superior aspect.Dissociation of the head from the femoral stem is confirmed.The root cause of the dissociation of the head from the femoral stem cannot be determined from the limited documentation provided.-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.A review of medical records with a clinical consultant indicated the photograph of the femoral head and stem demonstrates dissociation of the head from the stem.The trunnion of the stem is remodeled with significant material loss on the distal superior aspect.Dissociation of the head from the femoral stem is confirmed.The root cause of the dissociation of the head from the femoral stem cannot be determined from the limited documentation provided.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
Patient presented with right hip pain on (b)(6) 2023 and had x-ray.Referred to orthopedics.Attended orthopedic outpatients the next day (was able to walk in) x-ray showed head appeared to have disassociated from trunnion.Past history of a fall approximately 12 months ago.Revision right total hip replacement done today (b)(6) 2024.Accolade tmzf stem, v40 lfit 36mm head and trident insert removed.New trident x3 insert implanted with competitor distal fitting stem.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #5
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18934899
• Report Number: 0002249697-2024-00449
• Device Sequence Number: 6971206
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 04/30/2009
• Device Catalogue Number: 6021-0537
• Device Lot Number: 8621001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2004
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG