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	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	04/15/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture and loosening involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results:could not be performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant.Product history review: there have been no other similar events for the lot referenced.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not available.
Event or Problem Description
Postoperative diagnosis: patient underwent bilateral total hip replacement (b)(6) 2013.The patient had a left periprosthetic fracture with a loose femoral component.Revised on (b)(6) 2013.All components exchanged except cup and liner.

• 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: 8357504
• Report Number: 0002249697-2019-01116
• Device Sequence Number: 1683004
• Product Code: LPH
• UDI-Device Identifier: 04546540669537
• UDI-Public: 04546540669537
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 03/31/2018
• Device Catalogue Number: 6721-0837
• Device Lot Number: 42919005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/21/2019
• 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: 57 YR
• Patient Weight: 64