MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-11-54E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
As reported: "patient reported pain and instability in his right hip.Original hip replacement was performed in 2012 at an outside facility.Imaging showed a complete disassociation from the femoral head component off the trunnion of the femoral stem component.During the procedure adverse local tissue reaction was reported by the surgeon, as well as the trunnion wearing through the polyethylene liner of the hip and into the acetabular component damaging the locking mechanism.All 5 components implanted during the index procedure were stryker components, they were removed from the patient and revised with stryker components." spoke to rep, who provided the revision usage sheet.No further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• 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: 10740632
• Report Number: 0002249697-2020-02253
• Device Sequence Number: 3196226
• Product Code: LPH
• UDI-Device Identifier: 04546540432049
• UDI-Public: 04546540432049
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 08/31/2016
• Device Model Number: 502-11-54E
• Device Catalogue Number: 502-11-54E
• Device Lot Number: 37521301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/27/2020
• 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
• Patient Age: 76 YR