MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-00-36E

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported via our distributor that the consultant implanted a trident psl primary cup ref: 542-1-50e and then tried to implant a trident 36mm poly liner ref: 623-00-36e but ¿it would not fit¿.A 32mm poly liner ref: 623-00-32e was then implanted with no difficulties.

Manufacturer Narrative

An event regarding alleged "size/fit issue" involving a trident liner was reported.The event was not confirmed.Conclusions: the event was not confirmed and the root cause of the event could not be determined.Dimensional inspection of the returned device by the manufacturing engineer concluded " the complaint is deemed not to be manufacturing related." no further investigation is required.If additional relevant information becomes available this investigation will be reopened.

Event Description

It was reported via our distributor that the consultant implanted a trident psl primary cup ref: (b)(4) and then tried to implant a trident 36mm poly liner ref: (b)(4) but ¿it would not fit¿.A 32mm poly liner ref: (b)(4) was then implanted with no difficulties.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6593935
• MDR Text Key: 76147647
• Report Number: 0002249697-2017-01683
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039542
• UDI-Public: (01)07613327039542(11)170118(17)220131(10)58400101
• Combination Product (y/n): N
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

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 Expiration Date: 01/31/2022
• Device Model Number: 623-00-36E
• Device Catalogue Number: 623-00-36E
• Device Lot Number: 58400101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• 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