MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE NECK RESECTION GUIDE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1020-1100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported through a medwatch report "the initial ortho surgery performed.Post procedure x-ray performed and read by surgeon with findings of possible retained surgical item.The following day, pt returned to surgery for removal of retained instrument.Cutting guide was removed by ortho surgeon.Spoke to surgeon and he stated that it is a design issue.The risk director had discussion with surgeon that stated that he uses another brand of resection cutting guide at another facility, brand is unknown, but he explained the resection cutting guide had an extended metal piece at the top which keeps the guide from sliding.".

• Brand Name: ACCOLADE NECK RESECTION GUIDE
• 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: 9246956
• Report Number: 0002249697-2019-03631
• Device Sequence Number: 19470472
• Product Code: LPH
• UDI-Device Identifier: 07613327207958
• UDI-Public: 07613327207958
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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 Catalogue Number: 1020-1100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/28/2019
• 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