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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
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.

 
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Brand NameTRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
Type of DevicePROSTHESIS, 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 Key5235269
MDR Text Key31571344
Report Number0002249697-2015-03897
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143085
Number of Events Reported1
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
Date FDA Received11/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device Catalogue Number502-11-50D
Device LOT Number52253101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/19/2015 Patient Sequence Number: 1
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