MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0837
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient had groin/thigh pain requiring a revision of the femoral stem.We removed an accolade 2 stem and replaced it with a restoration modular.
Additional Manufacturer Narrative
Additional info patient details and implant date.An event regarding ¿reported groin/thigh pain involving an accolade stem and metal head¿was reported.¿¿the event¿was not¿confirmed.¿¿¿ method & results:¿ -device evaluation and results: not performed as product was not returned¿ -medical records received and evaluation:¿ the provided medical records were rejected for medical review by a clinician, who indicated the following: need operative reports, clinical/office notes, histopathology reports, serial x-rays and examination of the explanted components.-device history review: could not be performed as lot code information was not provided.¿ -complaint history review: could not be performed as lot code information was not provided.¿ conclusion:¿ the event could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided.¿ additional information including operative reports, clinical/office notes, histopathology reports, serial x-rays and examination of the explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient had groin/thigh pain requiring a revision of the femoral stem.We removed an accolade 2 stem and replaced it with a restoration modular.

• Brand Name: SIZE 8 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: 8372199
• Report Number: 0002249697-2019-01193
• Device Sequence Number: 16543867
• Product Code: LPH
• UDI-Device Identifier: 04546540669537
• UDI-Public: 04546540669537
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 6721-0837
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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: 69 YR