MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2208-2048A

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

The surgeon was doing a trident and he tried the trial cup assembled with the cup inserter.When he disassembled the trial cup from the inserter the thread was broken (the inserter cannot be threaded into a cup or a trial cup again).The surgeon discovered some metal particles when he unthreaded it from the inserter.The customer further reported that the surgeon tried with size 48 first and it didn't fit.Debris fell off when he and the scrub nurse unthreaded it.It was very well threaded, that's why 2 people were involved.Then he undertook acetabulum reaming (common procedure to do a greater reaming) and then he tried with size 50.He noticed debris again after unthreading the trial cup from the inserter.The surgeon did pulse lavage in the surgery field and believes that all debris was removed.There was a surgical delay of 5 minutes while this was done.The customer further reported that the surgeon tried with size 48 first and it didn't fit.Debris fell off when he and the scrub nurse unthreaded it.It was very well threaded, that's why 2 people were involved.Then he undertook acetabulum reaming (common procedure to do a greater reaming) and then he tried with size 50.He noticed debris again after unthreading the trial cup from the inserter.The surgeon did pulse lavage in the surgery field and believes that all debris was removed.There was a surgical delay of 5 minutes while this was done.

• Brand Name: TRIDENT ACET WINDOW TRIAL 48MM
• 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 SUZHIOU; no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou 21502 1; CN 215021
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5629041
• MDR Text Key: 44347175
• Report Number: 0002249697-2016-01505
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K151264
• 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
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2208-2048A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other