MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-10-32D

Device Problems Degraded (1153); Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported during a right primary hip procedure, it was noticed that the device had three additional 'nodes' around the peripheral locking mechanism preventing it from impacting into the shell.After the surgeon cut off one, the other two were found and the device was wasted.There was a 5 minute surgical delay to procure a second device.

Manufacturer Narrative

Reported event: an event regarding seating/locking issues involving a trident liner was reported.The seating/locking issues event was confirmed via photographs.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: photo shows a trident liner in a biohazard bag with what appears to be additional poly material around the peripheral locking mechanism.It is possible that the additional material led to the reported seating/locking issues event.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the global quality & operations (gqo) team reviewed the event and stated: due to the main nature of the complaint concerning a potential visual defect, a conclusive investigation would incorporate a thorough review of the device in order to substantiate the complaint and uncover potential causes.However, based on the available information presented in this complaint through a photograph with limited perspective views and suboptimal lighting, a conclusive investigation cannot be fully conducted.Thus, this complaint cannot be confirmed as a defect or specifically a manufacturing related defect without a returned device.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported during a right primary hip procedure, it was noticed that the device had three additional 'nodes' around the peripheral locking mechanism preventing it from impacting into the shell.After the surgeon cut off one, the other two were found and the device was wasted.There was a 5 minute surgical delay to procure a second device.

Manufacturer Narrative

Reported event: an event regarding damage and seating/locking issues involving a trident liner was reported.The damage and seating/locking issues events were confirmed via product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device was returned in like new condition.It was noted that the liner had damage around the peripheral locking mechanism confirming the reported damage and seating/locking issues events.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the global quality & operations (gqo) team reviewed the event and stated: i took a look at the relative dhr for this complaint piece and this product is 100% inspected by a vision system and is 100% inspected for workmanship which both would have caught if this feature was out of spec or if damage was present during manufacturing.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported during a right primary hip procedure, it was noticed that the device had three additional 'nodes' around the peripheral locking mechanism preventing it from impacting into the shell.After the surgeon cut off one, the other two were found and the device was wasted.There was a 5 minute surgical delay to procure a second device.

• Brand Name: TRIDENT 10 X3 INSERT 32MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11333322
• MDR Text Key: 234199921
• Report Number: 0002249697-2021-00270
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2021

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: 08/31/2021
• Device Model Number: 623-10-32D
• Device Catalogue Number: 623-10-32D
• Device Lot Number: 8W0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/17/2021; 05/24/2021
• Supplement Dates FDA Received: 04/12/2021; 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR