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

Catalog Number	6020-0537
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding disassociation and altr involving an accolade stem was reported.Disassociation was confirmed following a clinician review, altr is observed on the provided intraoperative image.Method & results: device evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs provided are of the recently explanted stem with tissue/blood around the stem body and a worn trunnion.An image of the patients blackened tissue was also provided which is indicative of altr.Medical records received and evaluation: the provided medical records were reviewed by a clinical consultant indicated: rejected for medical review.Need primary and revision operative reports, histopathology reports, serial x-rays and office/clinical notes, examination of the explanted components.Provided x-ray and pictures confirmed the dissociated stem and head.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.Conclusion: disassociation was confirmed following a clinician review, altr is observed on the provided intraoperative image; however, the provided records were rejected for medical review as it was indicated that the clinician needed primary and revision operative reports, histopathology reports, serial x-rays and office/clinical notes, examination of the explanted components to determine a root cause.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.
Event or Problem Description
It was reported that patient's left hip was revised.As reported by rep: "the femoral head and femoral stem neck trunion is worn.The femoral head disassociated".

• Brand Name: ACCOLADE 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
• MDR Report Key: 7991578
• Report Number: 0002249697-2018-03459
• Device Sequence Number: 11197355
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• 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: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 12/31/2009
• Device Catalogue Number: 6020-0537
• Device Lot Number: 10859403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/22/2018
• 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: 71 YR
• Patient Weight: 135