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

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: 1.Unknown restoration modular stem; cat# unknown; lot# unknown, 2 unknown restoration modular cone body; cat# unknown; lot# unknown, 3.Unknown 40mm femoral head; cat# unknown; lot# unknown, 4.Unknown 54mm shell; cat# unknown; lot# unknown, 5.Unknown screw 1 of 3; cat# unknown; lot# unknown, 6.Unknown screw 2 of 3; cat# unknown; lot# unknown, 7.Unknown screw 3 of 3; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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

As reported: "physician was explanting a cone/ conical restoration construct due to an active inflammation with the intent of placing an antibiotic spacer.While attempting to extract the conical stem with the mcreynolds slap hammer, the threads of the mcreynolds adaptor sheared off flush with the conical stem.Efforts to remove were unsuccessful and physician decided to convert to a girdlestone." this event is for the revision of patient's hip.Rep reported that the girdlestone is not a permanent procedure, it was performed as a stage 1 procedure after the surgical delay occured.The operative plan is to resect the femur to explant the remaining stem and revise the patient accordingly once the inflammation event is resolved.

• Brand Name: UNKNOWN 0° 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: merin grace ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7152428
• MDR Text Key: 96002906
• Report Number: 0002249697-2017-03756
• Device Sequence Number: 1
• Product Code: LZO
• 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: 12/28/2017

1 Device was Involved in the Event

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• 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: 64 YR