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

Model Number	623-10-32E
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional 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.Device evaluated by manufacturer? not available.
Event or Problem Description
Exploration &gluteal tendon repair right total hip replacement for pain on examination of acetabular liner (trident) it was discovered that there was wear due to position of 10 degree lip this was replaced with mdm dual mobility.
Additional Manufacturer Narrative
An event regarding wear involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis from the investigation record: not performed as no items were returned visual inspection: as per the attached picture of iiner, damage can be seen a little and biological particles including red blood spots are visible.Picture is attached for the reference.A functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: a review of the image provided shows some damage to the liner.While it is not possible to confirm the nature of the damage, it is likely due to explantation.Therefore, the reported event of wear cannot be confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays, pathology reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Exploration & gluteal tendon repair right total hip replacement for pain on examination of acetabular liner (trident) it was discovered that there was wear due to position of 10degree lip this was replaced with mdm dual mobility.

• Brand Name: TRIDENT 10 X3 INSERT 32MM ID
• 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: 9973079
• Report Number: 0002249697-2020-00764
• Device Sequence Number: 665690
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 07/31/2020
• Device Model Number: 623-10-32E
• Device Catalogue Number: 623-10-32E
• Device Lot Number: 52655901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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
• Patient Age: 76 YR