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

Catalog Number	6058-0637D
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0002249697-2023-00921
• Device Sequence Number: 7570791
• Product Code: LPH
• UDI-Device Identifier: 07613327020762
• UDI-Public: 07613327020762
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6058-0637D
• Device Lot Number: W98L5E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female