MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-3535
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "patient came to office on crutches.Revised femoral stem.Accolade primary stem neck failure, trunnion.Trunnion wore away.Femoral head popped off.Revision surgery to restoration modular.".
Additional Manufacturer Narrative
The event was confirmed via photos and medical review reported event: an event regarding disassociation and fretting involving an accolade stem which was mated with a lfit v40 cocr head was reported.The event was confirmed via photos and medical review.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: accolade stem had biological material throughout and the trunnion was severely worn confirming the reported disassociation and fretting events.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: confirmation: the event can be confirmed.Dissociation of head from stem with worn trunnion.Hazard/root cause: a hazard exists.The v40 cocr lfit head dissociated from the stem.There existed severe trunnion wear.The event is likely related to the lfit recall.Obtaining and examining the device may confirm the finding.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant revealed that the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "patient came to office on crutches.Revised femoral stem.Accolade primary stem neck failure, trunnion.Trunnion wore away.Femoral head popped off.Revision surgery to restoration modular.".

• Brand Name: ACCOLADE 132 SIZE 3.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10616615
• Report Number: 0002249697-2020-02029
• Device Sequence Number: 372801
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 12/31/2015
• Device Model Number: 6020-3535
• Device Catalogue Number: 6020-3535
• Device Lot Number: 35470904
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 147