MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ACCOLADE II STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Unstable (1667); Malposition of Device (2616)

Patient Problems Ambulation Difficulties (2544); Joint Laxity (4526); Unequal Limb Length (4534)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding alleged instability, limb length discrepancy and malposition involving an unknown implant accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not received.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as device is not identified properly.Complaint history review: not performed as device is not identified properly.Conclusions: an event regarding alleged instability, limb length discrepancy and malposition involving an unknown implant accolade stem was reported.The event was not confirmed.The exact cause of the event could not be determined because product is not properly identified and no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's right hip was revised due to instability.Surgeon also reported a limb length discrepancy (right approximately 2mm longer than the left) and stem malposition.The stem, head, and liner were revised to a competitor stem and head, adm/ mdm poly insert, and mdm metal liner.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN_ACCOLADE II STEM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12084113
• MDR Text Key: 258903185
• Report Number: 0002249697-2021-01105
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Weight: 99