MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 SECURFIT STEM WITH COLLAR; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Loss of Osseointegration (2408)

Patient Problem Injury (2348)

Event Date 01/15/2019

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.

Event Description

It was reported that the patient's right hip was revised due to disassociation.Originally, shell was suspected to be loose.Intra-operatively, shell was found to be well-fixed.The metal liner was found to not be locked into the shell.The stem was also found to not be well-fixed.A size 8 securfit stem with collar, 28 +10 metal head, adm/mdm liner construct were revised to a restoration modular stem construct with another metal head and a poly liner.

• Brand Name: SIZE 8 SECURFIT STEM WITH COLLAR
• Type of Device: 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8327905
• MDR Text Key: 135853540
• Report Number: 0002249697-2019-00958
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2019
• 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: 85 YR
• Patient Weight: 113