MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32F

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Ambulation Difficulties (2544)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: accolade plus tmzf hip stem #5; cat# 6021-0537 ; lot# 5308703.32mm 0mm v40 alumina head; cat# 6260-7-132 ; lot# 6167602.Trident psl ha cluster 56mm; cat# 542-11-56f ; lot# 92820310.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.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient's wife reported husband had bilateral hip surgery and been in pain for years.Stated his quality of life is diminishing, pain in groin area, parkinson's disease, high blood pressure.Kept dislocating during surgery for his left hip.Receiving injections for pain.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6517220
• MDR Text Key: 73556952
• Report Number: 0002249697-2017-01356
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2017
• 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): Other
• Patient Age: 80 YR