MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE C CS 132 NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6058-0435D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
Event or Problem Description
During the surgery the cement did not set up properly, it was removed from the canal, another batch was mixed and used.Upon the implantation of the second stem the femur was fractured.
Additional Manufacturer Narrative
An event regarding intraop fracture involving a accolade c cs 132 nk was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined as insufficient information was provided.Further information such as pre and post operative x-rays, medical records, operative reports, full patient history as well as follow up notes are needed to complete the investigation for determining a root cause.It must be noted that the patient had other co-morbidities.No further investigation for this event is possible at this time as insufficient information was received.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During the surgery the cement did not set up properly, it was removed from the canal, another batch was mixed and used.Upon the implantation of the second stem the femur was fractured.

• Brand Name: ACCOLADE C CS 132 NK
• 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: 6694471
• Report Number: 0002249697-2017-02135
• Device Sequence Number: 831765
• Product Code: LPH
• UDI-Device Identifier: 07613327020731
• UDI-Public: 07613327020731
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: 12/09/2020
• Device Catalogue Number: 6058-0435D
• Device Lot Number: MH67XN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 07/28/2017
• 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