MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-5537
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Notice received from patient's attorney alleges that patient had a stryker hip prosthesis which was subject to stryker's recall.It is alleged that the patient wound up having many of the signs and symptoms stryker said the defective hip would cause in its recall notice and in consultation with his orthopaedic surgeon has had a number of procedures to address the signs and symptoms he was displaying, ultimately resulting in the prosthesis being removed.
Additional Manufacturer Narrative
An event regarding loosening involving an accolade stem was reported.Conclusion: based on the provided information the product reported in this investigation did not contribute to the event.There were no allegations made against the accolade stem.The acetabular shell was noted as loose in the acetabulum.
Event or Problem Description
Notice received from patient's attorney alleges that patient had a stryker hip prosthesis which was subject to stryker's recall.It is alleged that the patient wound up having many of the signs and symptoms stryker said the defective hip would cause in its recall notice and in consultation with his orthopaedic surgeon has had a number of procedures to address the signs and symptoms he was displaying, ultimately resulting in the prosthesis being removed.

• Brand Name: ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5
• 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: 7614171
• Report Number: 0002249697-2018-01868
• Device Sequence Number: 11201172
• Product Code: LPH
• UDI-Device Identifier: 04546540510778
• UDI-Public: 04546540510778
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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: 06/30/2011
• Device Catalogue Number: 6021-5537
• Device Lot Number: 18606903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: 102