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	Bone Fracture(s) (1870); Injury (2348)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed by the clinician from the x-ray provided.Method and results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: the review of the provided medical records states the following: "rejected for medical review by the clinician today - x-ray confirms periprosthetic fracture, need primary and revision operative reports, post op x-ray of primary, need preop x-ray of periprosthetic fracture surgery." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot and sterile lot provided.Conclusion: the review of the provided medical records states the following: "rejected for medical review by the clinician today - x-ray confirms periprosthetic fracture, need primary and revision operative reports, post op x-ray of primary, need preop x-ray of periprosthetic fracture surgery." the exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative notes, additional serial post-operative x-rays of primary surgery and pre-op x-rays as well as follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and /or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised due to femoral periprosthetic fracture (possible cause or contributor for fracture not reported to the rep).An accolade ii stem, 40 +12 metal head, and 40f 0° liner were revised to an mdm/adm liner construct with competitor stem and head.Rep provided a post-revision x-ray and reported that additional x-rays, medical records, and additional information are not available.

• 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: 8373644
• Report Number: 0002249697-2019-01203
• Device Sequence Number: 2287936
• Product Code: LPH
• UDI-Device Identifier: 04546540669537
• UDI-Public: 04546540669537
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 6721-0837
• Device Lot Number: 65939601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/27/2019
• 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: 62 YR
• Patient Weight: 84