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

Catalog Number UNK_REC

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown trident cup.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.

Event Description

Sales rep stated that patient had a left hip implanted on an unknown date - accolade i stem, head, trident cup and liner.In 2012 the cup and liner were revised due to cup loosening.Surgeon implanted a zimmer cup and a 32 liner.Head and stem remained implanted and were well fixed.

Manufacturer Narrative

-medical records received and evaluation: the clinical consultant concluded: the first case concerns acetabular loosening in 2012 with exchange of the trident cup to a zimmer trilogy trabecular metal cup.The accolade tmzf stem was retained.This case cannot be solved because there is no info whatsoever regarding this event, no clinical info and no x-rays.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, x-rays, patient history & follow-up notes are needed to investigate this event.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Sales rep stated that patient had a left hip implanted on an unknown date - accolade i stem, head, trident cup and liner.In 2012 the cup and liner were revised due to cup loosening.Surgeon implanted a zimmer cup and a 32 liner.Head and stem remained implanted and were well fixed.

• Brand Name: UNKNOWN TRIDENT CUP
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5116580
• MDR Text Key: 27211334
• Report Number: 0002249697-2015-03206
• 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: Followup
• Report Date: 09/03/2015

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_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• 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): Required Intervention