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

Model Number	6721-0230
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Surgeon implanted accolade ii stem and noticed it sat lower than the broach.The stem was removed and a larger size was implanted.
Additional Manufacturer Narrative
Corrected information has been provided as the device was not returned for evaluation.An event regarding seating height involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for analysis.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as device return, x-rays, and revision operative report are needed to complete the investigation for determining root cause.If additional information and/or the device become available, this investigation will be reopened.Not returned to the manufacturer.
Event or Problem Description
Surgeon implanted accolade ii stem and noticed it sat lower than the broach.The stem was removed and a larger size was implanted.

• 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: 6532044
• Report Number: 0002249697-2017-01413
• Device Sequence Number: 11079813
• Product Code: LPH
• UDI-Device Identifier: 04546540669476
• UDI-Public: (01)04546540669476(11)160517(17)210531(10)55553402
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• 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,Followup
• Report Date (Section B): 07/07/2017

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: 05/31/2021
• Device Model Number: 6721-0230
• Device Catalogue Number: 6721-0230
• Device Lot Number: 55553402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/07/2017
• 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: Other
• Patient Age: 48 YR
• Patient Weight: 84