MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number 2099-2861

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem Ambulation Difficulties (2544)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: lfit morse taper head; cat # 01-2805; lot # vx62ny.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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.

Event Description

It was reported through the submission of a revision implant sheet that the patient's hip was revised.Comparing with the usage sheet from a prior revision, a 28 +5 femoral head and constrained insert were revised to a 28 +10 femoral head, constrained insert, and 2 additional screws.Additional information as per sales rep, "recurring instability and implant wear.Head and liner was exchanged a month prior and got infected.Went back in to replace head and liner again.".

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18180094
• MDR Text Key: 328611353
• Report Number: 0002249697-2023-01437
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 07613327031591
• UDI-Public: 07613327031591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2099-2861
• Device Lot Number: HD1M2K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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: 80 YR
• Patient Sex: Male