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

Catalog Number UNK_SHC

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Noise, Audible (3273)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Sales rep reported patient complained of squeaking of the hip.No pain was reported.

Manufacturer Narrative

-medical records received and evaluation: a review of the provided x-rays by a clinical consultant concluded: - excessive cup size with a protruding cup periphery beyond the acetabular bone has allowed impingement to occur between stem neck and cup sleeve rim with an indentation as consequence.A subluxation event caused a wear scar with increased friction in the bearing becoming manifest by squeaking.If additional information is received a supplemental report will be provided at the completion of the investigation.

Event Description

Sales rep reported patient complained of squeaking of the hip.No pain was reported.On (b)(6) 2017: it was discovered that excessive shell size contributed to impingement and subsequent squeaking.

• Brand Name: UNKNOWN TRIDENT SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6573037
• MDR Text Key: 75370200
• Report Number: 0002249697-2017-01572
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2011
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2006
• 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: 63 YR
• Patient Weight: 79