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	Pain (1994)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding patient factors involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: undated, unlabelled x-rays: ap and lat right hip - uncemented right tha, reduced, nominal with radiodense line around radiolucent line surrounding the uncoated distal stem consistent with successful biologic fixation.Mild lateral cortical hypertrophy in gruen zone 3 is noted.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no dated serial x-rays.Based upon the x-rays supplied, neither confirmation of the event description nor preparation of a medical report is possible for this case.Product history review: review of the device history records indicate the 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 lot referenced.Conclusions: it was reported that the patient hip was revised due to pain and some remodeling on cortex whereby the femoral stem was revised to restoration modular construct.Clinician review of provided medical records cannot confirm the reported event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as clinical or patient medical history (pmh), patient demographics, operative reports, examination of explanted components, and dated serial x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.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 had tha in 2016 and presented with pain.It was further reported that xrays show some remodeling on cortex and the patient required revision of the femoral stem to rest mod.

• 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: 11776964
• Report Number: 0002249697-2021-00799
• Device Sequence Number: 11845009
• Product Code: LPH
• UDI-Device Identifier: 04546540669520
• UDI-Public: 04546540669520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 05/31/2021
• Device Model Number: 6721-0737
• Device Catalogue Number: 6721-0737
• Device Lot Number: 55589209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/05/2021
• 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: 72