MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 542-11-56F

Device Problems Migration or Expulsion of Device (1395); Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/03/2016

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

The lawyer reported that the patient fell in his house on the (b)(6) 2016 for a shift in the hip prosthesis.Immediately after the injury was detected a manufacturing defect of the prostesis and the patient has undergone surgery for the removal of the damaged one that has been replaced.Update 10.14.2016: lawyer sent the ref.And lots of the products implanted due a coxarthrosis on (b)(6) 2005 and the photos of the same products explanted on (b)(6) 2016.

Manufacturer Narrative

An event regarding disassociation involving a metal femoral head and a hipstar stem was reported.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.The event relates to a failure between the stem-head locking mechanism.There was no allegation of failure against the trident shell.

Event Description

The lawyer reported that the patient fell in his house on the (b)(6) 2016 for a shift in the hip prosthesis.Immediately after the injury was detected a manufacturing defect of the prostesis and the patient has undergone surgery for the removal of the damaged one that has been replaced.Update 10.14.2016: lawyer sent the ref.And lots of the products implanted due a coxarthrosis on (b)(6) 2005 and the photos of the same products explanted on (b)(6) 2016.

• Brand Name: TRIDENT PSL HA CLUSTER 56MM
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6091805
• MDR Text Key: 59555304
• Report Number: 0002249697-2016-03563
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Catalogue Number: 542-11-56F
• Device Lot Number: 6420601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2003
• 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: 83 YR