MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 20MM; SCREW, FIXATION, BONE

Model Number	2030-6520-1
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant 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
It was reported that the patient's right hip was revised due to instability (possible cause or contributor for instability not reported to rep).A shell, two screws, and a liner were revised to a tritanium revision shell and mdm/ adm liner construct.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
Additional Manufacturer Narrative
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
It was reported that the patient's right hip was revised due to instability (possible cause or contributor for instability not reported to rep).A shell, two screws, and a liner were revised to a tritanium revision shell and mdm/ adm liner construct.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8443181
• Report Number: 0002249697-2019-01411
• Device Sequence Number: 16212576
• Product Code: HWC
• UDI-Device Identifier: 07613327036985
• UDI-Public: 07613327036985
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2020

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: 01/31/2023
• Device Model Number: 2030-6520-1
• Device Catalogue Number: 2030-6520-1
• Device Lot Number: DJ5HN9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 11/22/2020
• 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: 63 YR