MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0535
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
On (b)(6) 2019 the patient was felt and right femoral neck fracture occurred.(b)(6) 2019 treated with implanting the stem by surgical procedure.(b)(6) 2019 treated manually due to dislocation.(b)(6) 2019 the patient was discharged.
Additional Manufacturer Narrative
An event regarding dislocation involving an accolade stem was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.The patient reported a manual treatment due to dislocation, which is likely happened between a femoral head device and liner/ acetabulum.The femoral head and/or liner details were not reported and it is unknown if the femoral head and/or liner are stryker devices.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
On (b)(6) 2019 the patient was felt and right femoral neck fracture occurred.On (b)(6) 2019 treated with implanting the stem by surgical procedure.On (b)(6) 2019 treated manually due to dislocation.On (b)(6) 2019 the patient was discharged.

• Brand Name: SIZE 5 ACCOLADE II 132 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: 9624159
• Report Number: 0002249697-2020-00152
• Device Sequence Number: 585854
• Product Code: LPH
• UDI-Device Identifier: 04546540664488
• UDI-Public: 04546540664488
• Combination Product (Y/N): N
• 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): 03/18/2020

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 Model Number: 6720-0535
• Device Catalogue Number: 6720-0535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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