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

Catalog Number 502-11-56F

Device Problems Failure to Disconnect (2541); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure, the surgeon could not disconnect the bolt from the cup.The procedure was a left total hip, not a revision.The same instrument was used to impact the second cup without any problems and the procedure was completed successfully.There was an approximate delay of 20 minutes.There was no adverse consequence to the patient or user.

Manufacturer Narrative

An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no information was received for review with the clinical consultant.Device history review : all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review : there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return of device are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

During the procedure, the surgeon could not disconnect the bolt from the cup.The procedure was a left total hip, not a revision.The same instrument was used to impact the second cup without any problems and the procedure was completed successfully.There was an approximate delay of 20 minutes.There was no adverse consequence to the patient or user.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5854002
• MDR Text Key: 52309940
• Report Number: 0002249697-2016-02540
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 502-11-56F
• Device Lot Number: 53950201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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): Other