MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 2 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0230
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision surgery involving an accolade stem was reported.The revision surgery event was confirmed based on a revision implant sheet that was made available, this confirms revision of the device.Method & results: device evaluation and results:not performed as the device was not returned.Medical records received and evaluation: no information was received for review with the clinical consultant.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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.The following devices were also listed in this report: delta v-40 ceramic head 32/-4; 6570-0-032; 38683301; trident 0 deg x3 insert 32mm head; 623-00-32d; mleyxw.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's right hip was revised.Revision implants were a restoration modular stem, 22.2 +0 lfit head, mdm/adm liner construct, and one screw.

• Brand Name: SIZE 2 ACCOLADE II 127 DEG
• 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: 7806483
• Report Number: 0002249697-2018-02651
• Device Sequence Number: 1143424
• Product Code: LPH
• UDI-Device Identifier: 04546540669476
• UDI-Public: 04546540669476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 04/30/2017
• Device Catalogue Number: 6721-0230
• Device Lot Number: 39450006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial 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: 54 YR