MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DUAL GEO.M/S SCREWLESS CUP 58MM; MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

Catalog Number 2072-0058

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that a stryker constrained liner came out of its cup.The patient was admitted to hospital for an acetabular revision.

• Brand Name: DUAL GEO.M/S SCREWLESS CUP 58MM
• Type of Device: MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6197843
• MDR Text Key: 63066048
• Report Number: 0002249697-2016-03985
• Device Sequence Number: 1
• Product Code: JDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925883
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2072-0058
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• 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: 82 YR
• Patient Weight: 86