MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-00-32D

Device Problem Naturally Worn (2988)

Patient Problems Injury (2348); Hip Fracture (2349)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

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

During a thp revision from a primary accolande tmzf/trident titanium in (b)(6) 2019, the surgeon discovered that the polyethylene was damaged/scratched without noticing corpora libera.No damage noticeable at the old v40 head.The damaged x3 polyethylene on this short term is concerning the costumer about the quality.Update: "reason for revision (please include any reported patient complaints, pre-operative diagnoses, and intra-operative findings): periprosthetic fracture".

Manufacturer Narrative

Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed by evaluation of the returned device.Method & results: product evaluation and results: damage consistent with the explantation process was observed on the proximal and distal surfaces of the insert.Damage consistent with burnishing, scratching, and third body indentations were observed on the articulating surface of the insert; these are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: evaluation of the returned device revealed that damage consistent with the explantation process was observed on the proximal and distal surfaces of the insert.Damage consistent with burnishing, scratching, and third body indentations were observed on the articulating surface of the insert; these are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During a thp revision from a primary accolande tmzf/trident tritanium in (b)(6) 2019, the surgeon discovered that the polyethylene was damaged/scratched without noticing corpora libera.No damage noticeable at the old v40 head.The damaged x3 polyethylene on this short term is concerning the costumer about the quality.Update: "1.Reason for revision (please include any reported patient complaints, pre-operative diagnoses, and intra-operative findings): periprostetic fracture.".

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• 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: 10072605
• MDR Text Key: 191480928
• Report Number: 0002249697-2020-00952
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039467
• UDI-Public: 07613327039467
• 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
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 623-00-32D
• Device Catalogue Number: 623-00-32D
• Device Lot Number: 75217601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention