MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_HIP; UNKNOWN HIP IMPLANT

Catalog Number UNK_JR

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Metal Related Pathology (4530)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported by an attorney that plaintiff underwent a revision of an unknown hip for unknown reasons.

Manufacturer Narrative

Corrected data: product information has been received indicating that this device falls under fda registration# 3005985723.A new, initial mdr (mfr# 3005985723-2024-00051) has been submitted using fda registration# 3005985723, accordingly.Any further reports for this incident will be submitted under mfr# 3005985723-2024-00051.

Event Description

It was reported by an attorney that plaintiff underwent a revision of an unknown hip for unknown reasons.

• Brand Name: UNKNOWN_HIP
• Type of Device: UNKNOWN HIP IMPLANT
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8274330
• MDR Text Key: 133990505
• Report Number: 0002249697-2019-00322
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024
• 2 Devices were Involved in the Event: 1 2

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_JR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/29/2024
• 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 Sex: Male