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

Catalog Number	502-11-44B
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A 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.
Event or Problem Description
It was reported that the patient's right hip was revised.Patient was reportedly doing fine for 3 post- op months, developed pain in the fourth month.X-rays showed that the shell had migrated.The trident hemispherical shell, 32 -4 lfit head, and trident x3 insert were revised to a tritanium hemispherical cluster hole shell with 2 screws, trident x3 insert and 32+0 head.Rep confirmed there are no allegations against the liner or head.Rep provided a primary webops report and revision usage sheet, and reported that no further information is available.

• 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: 8854701
• Report Number: 0002249697-2019-02733
• Device Sequence Number: 2267642
• Product Code: LPH
• UDI-Device Identifier: 04546540431998
• UDI-Public: 04546540431998
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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: 01/31/2024
• Device Catalogue Number: 502-11-44B
• Device Lot Number: 69953401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/02/2019
• 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: 70 YR
• Patient Weight: 57