MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6721-0535

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/11/2022

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to stem loosening.A stem, head and liner were revised to a restoration modular stem construct with a new head and liner.Rep confirmed there are no allegations against the revised head or liner.

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.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.

Event Description

It was reported that the patient's right hip was revised due to stem loosening.A stem, head and liner were revised to a restoration modular stem construct with a new head and liner.Rep confirmed there are no allegations against the revised head or liner.

Manufacturer Narrative

Reported event: an event regarding loosening involving a accolade stem was reported.The event was confirmed via clinician review.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 stated" the ap hip x-ray demonstrates bone prosthetic interface lucencies about the medial and lateral of the proximal femoral component.These findings are consistent with stem loosening.It is confirmed that loss of fixation of a pressfit stem in a total hip occurred.The root cause of this loss of fixation cannot be determined from this limited documentation." product history review: review of the device history records indicate 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 patient was revised due to stem loosening.The event was confirmed via clinician review of provided medical records.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.

• Brand Name: SIZE 5 ACCOLADE II 127 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15698097
• MDR Text Key: 302688971
• Report Number: 0002249697-2022-01573
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669506
• UDI-Public: 04546540669506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 6721-0535
• Device Catalogue Number: 6721-0535
• Device Lot Number: 83160004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 125 KG