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

Model Number	690-00-28F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The following was reported: bipolar outer femoral head was luxated / detached from the trident 10 ° constrained acetabular insert while in patient.Components were implanted in patient on (b)(6) 2020.
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.H3 other text: device not returned.
Event or Problem Description
The following was reported: bipolar outer femoral head was luxated / detached from the trident 10 ° contrained acetabular insert while in patient.Components were implanted in patient on (b)(6) 2020.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• 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: 10725214
• Report Number: 0002249697-2020-02218
• Device Sequence Number: 1679537
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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 Model Number: 690-00-28F
• Device Catalogue Number: 690-00-28F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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