MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0737
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/26/2020
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 relevant reported discrepancies.There have been no other similar 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.Device not returned.
Event or Problem Description
Procedure: patient underwent index tha on (b)(6) 2020.Then the patient had a periprosthetic fracture (b2) of the femur.All components where exchanged except the cup on (b)(6) 2020.
Event or Problem Description
Procedure: patient underwent index tha on (b)(6) 2020.Then the patient had a periprosthetic fracture (b2) of the femur.All components where exchanged except the cup on (b)(6) 2020.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed by clinician review.Method & results: - device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.- clinician review: the available medical records were provided to the consulting clinician for a review which noted, "the event was confirmed, a periprosthetic fracture led to revision tha and orif of the femur.The root cause of the revision was the b2 periprosthetic fracture.The root cause of the fracture was unclear.Clinical records and patient history would be required to assess whether there was trauma leading to the fracture.Additional x-rays would be required to rule-out intraoperative nondisplaced fracture as an inciting issue.The event was not related to the implants themselves." - device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.- complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient had a periprosthetic fracture.The available medical records were provided to the consulting clinician for a review which noted that the event was confirmed, a periprosthetic fracture led to revision tha and orif of the femur.The root cause of the revision was the b2 periprosthetic fracture.The root cause of the fracture was unclear.Clinical records and patient history would be required to assess whether there was trauma leading to the fracture.Additional x-rays would be required to rule-out intraoperative nondisplaced fracture as an inciting issue.The event was not related to the implants themselves.The exact cause could not be determined because insufficient information was provided.Additional information including operative reports are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.

• Brand Name: SIZE 7 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: 11045580
• Report Number: 0002249697-2020-02735
• Device Sequence Number: 1265343
• Product Code: LPH
• UDI-Device Identifier: 04546540669520
• UDI-Public: 04546540669520
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 10/31/2024
• Device Model Number: 6721-0737
• Device Catalogue Number: 6721-0737
• Device Lot Number: 74234201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/26/2021
• 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: 71 YR
• Patient Weight: 93