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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Injury (2348); Hip Fracture (2349)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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".
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10072605
• Report Number: 0002249697-2020-00952
• Device Sequence Number: 3752458
• Product Code: LPH
• UDI-Device Identifier: 07613327039467
• UDI-Public: 07613327039467
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• 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 Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention