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

Model Number	508-11-50D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/07/2007
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.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Additional devices listed in this event: catalog 6191-1-001, description: simplex p full dose 1 pack, lot: rkn302 x (2).Catalog 2030-6516-1, description: 6.5 cancellous bone screw 16mm, lot: 38445410c.Catalog 2030-6520-1, description: 6.5 cancellous bone screw 20mm, lot: 0ndmra.Catalog 2030-6520-1 description 6.5 cancellous bone screw 20mm lot: 34290302.Catalog 64956030, description: gmrs extension piece 30mm, lot: lacyh.Catalog 64951002, description: gmrs prox fem com trochanteric, lot: lsopl.Catalog 64853611, description: mrs fem stem w/o body 11x203mm, lot: tec058a1.Catalog 6260-9-322, description: 22.2mm +8 lfit v40 head, lot: 18993402.At this time, it can not be concluded which, if any devices caused or contributed to the patients' experience.
Event or Problem Description
Patient stated she has been experiencing excruciating pain.

• Brand Name: TRIDENT HEMISPHERICAL MULTI
• 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: 10583317
• Report Number: 0002249697-2020-01982
• Device Sequence Number: 19635393
• Product Code: LPH
• UDI-Device Identifier: 04546540432193
• UDI-Public: 04546540432193
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: 12/31/2012
• Device Model Number: 508-11-50D
• Device Catalogue Number: 508-11-50D
• Device Lot Number: 387872G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/24/2020
• 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: Other
• Patient Age: 35 YR
• Patient Weight: 66