MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE C CS 132 NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6058-0637D

Device Problem Difficult to Insert (1316)

Patient Problem Cardiac Arrest (1762)

Event Date 07/28/2023

Event Type  Injury  

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.H3 other text : device not returned.

Event Description

The following occurred during a primary left hemi hip procedure: surgeon trialed for an accolade c stem and unipolar sleeve and head.After trialing, the surgeon cemented in the real stem (competitor cement).When impacting the new sleeve and head, it would not lock to the stem (surgeon attempted 6 times).Surgeon then used the previously used trials, which would not lock.A second sleeve and head were used and would not lock after 3 attempts.Finally, the surgeon felt he had the sleeve and head 'wedged onto' the stem.Anesthesiologist indicated that it was time to turn the patient over and the patient coded (it was noted that due to the patient's age and health issues, it was difficult to get her cleared for surgery in the first place).Patient was closed with the final implants in situ.The rep last saw the patient alive and has not been notified of death.Overall surgical delay was 3 minutes.

• Brand Name: ACCOLADE C CS 132 NK
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17608678
• MDR Text Key: 321803430
• Report Number: 0002249697-2023-00921
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327020762
• UDI-Public: 07613327020762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6058-0637D
• Device Lot Number: W98L5E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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): Other
• Patient Age: 97 YR
• Patient Sex: Female