MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28G; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-28G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/24/2020
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
This pi is for patient 1 of 2.While reporting a revision of another patient's hip due to dislocation of a constrained liner from a trident ii shell, the surgeon reported that he followed up with three additional patients that had trident ii shells with constrained liners.Two of the three patients have responded that they have hip pain.Though not revised and not confirmed as of the time of report, the surgeon suspects those patients may also have disassociated constrained liners.The third additional patient has not responded as of the time of report.None of the lot codes for either the inserts or the shells are the same across the three patients (the one revised, and the two reporting pain).Update 25/march/2020 wg: upon follow-up visit to surgeon, patient specified minor incisional pain.After radiological imaging and traction of the leg, the patient's hip construct was determined to be well-fixed with no devices dislocated or disassociated.Rep reported that the surgeon will not release any further information.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28G
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9979218
• Report Number: 0002249697-2020-00780
• Device Sequence Number: 2089487
• Product Code: KWZ
• UDI-Device Identifier: 07613327025583
• UDI-Public: 07613327025583
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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: 05/31/2023
• Device Model Number: 690-00-28G
• Device Catalogue Number: 690-00-28G
• Device Lot Number: K50NMN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/20/2020
• 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: 84 YR