MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0637
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026); Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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
According to the surgeon the patient heard a ¿pop¿ noise and right away set an appointment.The surgeon had xrays taken of the right hip and noticed the femoral head was seated on accolade tmzf stem in an incorrect position.The surgeon reviewed x rays with his colleagues and they agreed they should revise the right hip.Hip was revised on wed (b)(6) 2018 with stryker modular hip replacement system.
Additional Manufacturer Narrative
Additional information: event executive summary: an event regarding disassociation involving an accolade stem that was mated with a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were received for evaluation.Device history review: indicated 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: the exact cause of the reported event could not be confirmed based on the information provided.Further information such as such product return, pre and post operative x-rays, operative reports, as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
According to the surgeon the patient heard a ¿pop¿ noise and right away set an appointment.The surgeon had xrays taken of the right hip and noticed the femoral head was seated on accolade tmzf stem in an incorrect position.The surgeon reviewed x rays with his colleagues and they agreed they should revise the right hip.Hip was revised on wed (b)(6) 2018 with stryker modular hip replacement system.Update: as reported in how was issue noticed: patient heard a ¿pop¿ noise from hip right hip.The original date of surgery was on (b)(6) 2007.Noise from patient¿s right hip was heard by patient around on (b)(6) 2018.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #6
• 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: 7695046
• Report Number: 0002249697-2018-02199
• Device Sequence Number: 1269571
• Product Code: LPH
• UDI-Device Identifier: 04546540510716
• UDI-Public: 04546540510716
• 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: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 05/31/2011
• Device Catalogue Number: 6021-0637
• Device Lot Number: 18035601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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: 73 YR
• Patient Weight: 111