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

Catalog Number	6020-3535
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
Sales rep reported "doctor says there was excessive wear between head and trunnion of stem.Patient presented with adverse local tissue reaction to metal debris resulting in pseudo tumor." spoke to rep, he stated the explants are not being returned and no additional information will be available.
Additional Manufacturer Narrative
D4 catalog number was corrected.An event regarding disassociation and altr involving a accolade stem.The event was confirmed by medical review.Method & results: device evaluation and results: visual,functional,material and dimensional inspection not performed as the product is not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant rejected and stated that x-ray confirms disassociation of the head and photo shows damaged trunnion, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x- rays and examination of explanted components.Device history review: all 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.Conclusions: it was reported that patient was revised due to wear between head and trunnion, resulting metal debris converted into pseudo tumor.A review of the provided medical records and or x-rays by a clinical consultant rejected and stated that - x-ray confirms disassociation of the head and photo shows damaged trunnion, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x- rays and examination of explanted components.The exact cause of the event could not be determined required further information as well as patient history are needed to complete the investigation for determing the root cause.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Sales rep reported "doctor says there was excessive wear between head and trunnion of stem.Patient presented with adverse local tissue reaction to metal debris resulting in pseudo tumor." spoke to rep, he stated the explants are not being returned and no additional information will be available.

• 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: 9253089
• Report Number: 0002249697-2019-03640
• Device Sequence Number: 16610558
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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: 12/01/2015
• Device Catalogue Number: 6020-3535
• Device Lot Number: 35098901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/15/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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: 75 YR
• Patient Weight: 113