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

Model Number	623-10-32F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/01/2020
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.
Event or Problem Description
Customer reported that a patient who underwent a hybrid total hip replacement, presented with pain a few days later.Following x-rays, the physician alleged that the liner disengaged out of place and decided to change it.From hospital's internal investigation, they suggested that the liner showed a crack through the liner itself and also damaged about the top (they remarked whether this was due to the liner becoming disengaged?).Hospital is querying whether similar events have been reported previously.Update 05/12/2020: "please clarify what hybrid total hip replacement means in this case.Uncemented cup and cemented stem.Please provide the catalog number and lot code for the acetabular shell.Ref: 542-11-54f lot: lt0e3v.Is ¿about the top¿ referring to the dome or the rim of the liner.The rim of the liner".

• 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: 10092692
• Report Number: 0002249697-2020-00979
• Device Sequence Number: 3497381
• Product Code: LPH
• UDI-Device Identifier: 07613327039863
• UDI-Public: 07613327039863
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 623-10-32F
• Device Catalogue Number: 623-10-32F
• Device Lot Number: YN60DW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/27/2020
• 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