MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT CUP TIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1440-1310

Device Problems Mechanical Problem (1384); Connection Problem (2900); Detachment of Device or Device Component (2907)

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a left hip primary surgery, the trident cup tip did not connect with inserter.

Manufacturer Narrative

Reported event: an event regarding assembly issues involving a trident cup tip was reported.The event was confirmed.Device evaluation and results: the trident tip was returned in damaged condition and the spring cut tip was missing.Material analysis and functional inspection of the returned device not performed as the device was returned damaged (missing the spring-cut tip).Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.The event was confirmed as per visual inspection of the returned device which shows the device was damaged.Material analysis and functional inspection of the returned device not performed as the device was returned damaged (missing the spring-cut tip).No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

During a left hip primary surgery, the trident cup tip did not connect with inserter.

• Brand Name: TRIDENT CUP TIP
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6240709
• MDR Text Key: 64930036
• Report Number: 0002249697-2017-00165
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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: 04/10/2017

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 Catalogue Number: 1440-1310
• Device Lot Number: 74546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2006
• 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
• Patient Age: 51 YR