MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0230
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	04/21/2021
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.
Event or Problem Description
The head dissociated from the stem.According to the image, it seems to be metallosis.Revision is scheduled on (b)(6) 2021.Probably due to wear.Surgeon suspected the product issue.
Event or Problem Description
The head dissociated from the stem.According to the image, it seems to be metallosis.Revision is scheduled on (b)(6) 2021.Probably due to wear.Surgeon suspected the product issue.
Additional Manufacturer Narrative
An event regarding disassociation and wear/metallosis involving an accolade stem was reported.The event was confirmed.Method & results: -product evaluation and results: the device is returned in a used condition.Damage is 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 the provided medical information by a clinical consultant indicated: undated, unlabelled x-ray - ap right hip - uncemented tha with stem trunnion disassociated, dislocated and eroded from modular head which remains in acetabular component.Radiodense debris noted around hip joint.No clinical or pmh, no patient demographics, no confirmation of revision surgery or operative reports, no examination of explanted components.While the single x-ray appears to confirm the event description, insufficient data is presented to create a medical report for this case.-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 head dissociated from the stem.It was also reported that it seems to be metallosis.The device is returned in a used condition.Damage is 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 of the provided x-ray indicated that uncemented tha with stem trunnion disassociated, dislocated and eroded from modular head which remains in acetabular component.Radiodense debris noted around hip joint.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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation, altr and wear/metallosis involving an accolade stem was reported.The event was confirmed.Method & results: product evaluation and results: the device is returned in a used condition.Damage is 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 the provided medical information by a clinical consultant indicated: confirmation: a revision surgery was performed for severe trunnionosis and head stem disassociation.There was pseudotumor, severe metallosis and the explant showed severe trunnion wear and notching.The implants were not identified but a v40-tmzf combination should be ruled out as well as potential recall based on lot numbers.These factors were not confirmed.Root cause: the root cause of the revision was severe trunnion wear leading to disassociation of the head from the stem.The root cause cannot be determined without additional medical records and review of the implant lot numbers.Product history review: review of the device history records indicate 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 head dissociated from the stem.It was also reported that it seems to be metallosis.The device is returned in a used condition.Damage is consistent with the loss of taper lock was observed on the head and stem of the returned devices.Clinician review of the provided medical records confirmed that a revision surgery was performed for severe trunnionosis and head stem disassociation.There was pseudotumor, severe metallosis and the explant showed severe trunnion wear and notching.Severe trunnion wear leading to disassociation of the head from the stem.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The head dissociated from the stem.According to the image, it seems to be metallosis.Revision is scheduled on (b)(6) 2021.Probably due to wear.Surgeon suspected the product issue.*update on 23 nov 2021 per clinician review: "a revision surgery was performed for severe trunnionosis and head stem disassociation.There was pseudotumor, severe metallosis and the explant showed severe trunnion wear and notching.".

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11840073
• Report Number: 0002249697-2021-00868
• Device Sequence Number: 3576036
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2021

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: 08/31/2015
• Device Model Number: 6021-0230
• Device Catalogue Number: 6021-0230
• Device Lot Number: 34325806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 11/24/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 10/06/2021; 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2010
• 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 Sex: Female