MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0435
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	09/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.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: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: revision surgery for dissociation of a cocr lfit v40 head from an accolade tmzf stem approximately 10 years after the index procedure.Event confirmation: a revision surgery, head dissociation, and trunnion wear were confirmed from the surgeon¿s operative note.No radiographs were provided for additional event confirmation.Implants were not provided for examination and pathologic exam was not provided for review.Root cause: the root cause of the revision was head dissociation from the stem and presence of trunnion wear.The root cause of the trunnion wear and head-stem failure cannot be ascertained without additional medical information.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.Conclusion: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: revision surgery for dissociation of a cocr lfit v40 head from an accolade tmzf stem approximately 10 years after the index procedure.Event confirmation: a revision surgery, head dissociation, and trunnion wear were confirmed from the surgeon¿s operative note.No radiographs were provided for additional event confirmation.Implants were not provided for examination and pathologic exam was not provided for review.Root cause: the root cause of the revision was head dissociation from the stem and presence of trunnion wear.The root cause of the trunnion wear and head-stem failure cannot be ascertained without additional medical information.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.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 by the patient's attorney as a result of a legal claim that allegedly in (b)(6) of 2011 an lfit anatomic v40 femoral head was implanted in the patient's right hip and the patient was revised on (b)(6), 2021.Stryker was made aware of this event via legal counsel.Update as per med review dated 17 february 2023: revision surgery for dissociation of a cocr lfit v40 head from an accolade tmzf stem approximately 10 years after the index procedure.The cup was at a high abduction angle of high 500 range on x-ray.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16492350
• Report Number: 0002249697-2023-00224
• Device Sequence Number: 15055659
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• 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: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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: 11/30/2015
• Device Model Number: 6020-0435
• Device Catalogue Number: 6020-0435
• Device Lot Number: 35131106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male