MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-11-50D

Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Uf report # (b)(4) reported the following: the patient originally underwent a total hip arthroplasty by the hospital's orthopedic surgeon on (b)(6) 2015.The patient was reported to have degenerative joint disease of the right hip that led to the procedure.No complications were reported with follow up physical therapy and anticoagulation ordered.After the surgery less than month, the patient reported to have had some maneuvers in a lounge chair and dislocated the hip.The hip was reported to be replaced twice and noted as unstable.The patient reported she went to the hospital's er and it was placed back in as well as placed in a knee immobilizer.The patient also reported while in the eye doctor's office she twisted a little and the hip came out.The patient presented back to the hospital on (b)(6) 2015 for revision surgery and a bipolar type hip replacement put back in her.The surgeon explained risks to the patient that he could not guarantee repeat dislocation and the patient elected to do the surgery.The procedure on (b)(6) 2015 for revision of acetabular component and changing the liner to a bipolar dual lock stryker liner was performed with no complications reported.

Manufacturer Narrative

This event was identified as a duplicate previously reported under (b)(4).Investigation results and conclusions will be provided under mfr #0002249697-2015-03931.

Event Description

(b)(4): the patient originally underwent a total hip arthroplasty by the hospital's orthopedic surgeon on (b)(6) 2015.The patient was reported to have degenerative joint disease of the right hip that led to the procedure.No complications were reported with follow up physical therapy and anticoagulation ordered.After the surgery less than month, the patient reported to have had some maneuvers in a lounge chair and dislocated the hip.The hip was reported to be replaced twice and noted as unstable.The patient reported she went to the hospital's er and it was placed back in as well as placed in a knee immobilizer.The patient also reported while in the eye doctor's office she twisted a little and the hip came out.The patient presented back to the hospital on (b)(6) 2015 for revision surgery and a bipolar type hip replacement put back in her.The surgeon explained risks to the patient that he could not guarantee repeat dislocation and the patient elected to do the surgery.The procedure on (b)(6) 2015 for revision of acetabular component and changing the liner to a bipolar dual lock stryker liner was performed with no complications reported.Update: this event was identified as a duplicate previously reported under (b)(4).Investigation results and conclusions will be provided under mfr #0002249697-2015-03931.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5235269
• MDR Text Key: 31571344
• Report Number: 0002249697-2015-03897
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

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 Expiration Date: 07/31/2020
• Device Catalogue Number: 502-11-50D
• Device Lot Number: 52253101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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