MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE HFX SIZE #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6077-0335
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
During a hemiarthroplasty for a hip fracture at (b)(6) hospital in (b)(6) the surgeon opened a size 3 accolade hfx stem and noticed small, white particles on the neck of the stem.Dr.(b)(6) commented that the neck of the stem was not in the protective foam when he opened the stem on the back table.This item was set aside on the back table and not implanted.A second stem was opened and implanted into the patient.Update (b)(6) 2018: rep reported that the device was in protective foam but the neck was not properly seated, pressing it against the plastic tray.

• Brand Name: ACCOLADE HFX SIZE #3
• 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: 7703939
• Report Number: 0002249697-2018-02233
• Device Sequence Number: 600632
• Product Code: LPH
• UDI-Device Identifier: 07613327021196
• UDI-Public: 07613327021196
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 6077-0335
• Device Lot Number: 5P61AT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/19/2018
• 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: Other
• Patient Age: 88 YR