MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 0° CONSTRAINED F LINER HIP IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding infection involving a liner was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned; medical records received and evaluation: no medical records were received for review with a clinical consultant; device history review: could not be performed as lot code information was not provided. Complaint history review: could not be performed as lot code information was not provided. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information including operative reports, pathology reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened. The following devices were also listed in this report: 60mm tritanium revision shell; cat#unk_jr; lot#unknown; screw 1 of 3; cat#unk_jr; lot#unknown; screw 2 of 3; cat#unk_jr; lot#unknown; screw 3 of 3; cat#unk_jr; lot#unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.

Event Description

It was reported that patient's left hip was revised due to infection (infection reported by surgeon, unknown infecting microorganism, unknown if infection clinically confirmed). A 60mm tritanium shell with 3 screws, a 0° constrained f liner, competitor stem and head were revised to a competitor construct.

• Brand Name: UNKNOWN 0° CONSTRAINED F LINER
• 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: 8204660
• MDR Text Key: 131706555
• Report Number: 0002249697-2018-04188
• Device Sequence Number: 1
• Product Code: KWA
• 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

• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2018
• 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 Treatment Data

Date Received: 12/28/2018 Patient Sequence Number: 1