MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SCREW, FIXATION, BONE

Model Number	2030-6530-1
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	05/08/2020
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
Patient required a revision of the cup today due to it loosening.The original case was (b)(6) 2020; due to patient anatomy at that time, the surgeon opted to use a trident tritanium multihole (509-02-56e).Surgeon requested screws.Torx screws were provided (2030-6516-1 and 2030-6530-1).Liner was impacted and the femur was completed.I became aware today (5/8/2020) that the patient required a revision of the cup.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a screw.The event was not confirmed.Method & results: product evaluation and results: visual, functional,dimensional and material analysis not performed as no device was returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant rejected stating: undated ap pelvis labelled "planned" with uncemented templates of left tha in situ, no screws in acetabulum, reduced and nominal position.Implant labels dated (b)(6) 2020 : 56 trident tritanium hemispherical shell, 36/0 degree x-3 poly insert, 2 torx cancellous screws, #7 anato hip stem, 36/-2,5 v-40 biolox head.No clinical or pmh, no patient demographics, no operative reports, no post op x- rays, no exam of explanted components.The implant labels confirm the use of torx screws noted in the event description, but the loose cup is not confirmed.No medical report is possible based upon the information supplied." product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot.Conclusion: it was reported that patient required a revision of the cup today due to it loosening.The event is not confirmed.A review of the provided medical records and/or x-rays by a clinical consultant rejected stating: undated ap pelvis labelled "planned" with uncemented templates of left tha in situ, no screws in acetabulum, reduced and nominal position.Implant labels dated (b)(6) 2020: 56 trident tritanium hemispherical shell, 36/0 degree x-3 poly insert, 2 torx cancellous screws, #7 anato hip stem, 36/-2,5 v-40 biolox head.No clinical or pmh, no patient demographics, no operative reports, no post op x- rays, no exam of explanted components.The implant labels confirm the use of torx screws noted in the event description, but the loose cup is not confirmed.No medical report is possible based upon the information supplied." the exact cause of the event could not be determined because no further information such as the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient required a revision of the cup today due to it loosening.The original case was (b)(6) 2020; due to patient anatomy at that time, the surgeon opted to use a trident tritanium multihole (509-02-56e).Surgeon requested screws.Torx screws were provided (2030-6516-1 and 2030-6530-1).Liner was impacted and the femur was completed.I became aware today ((b)(6) 2020) that the patient required a revision of the cup.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10105511
• Report Number: 0002249697-2020-01000
• Device Sequence Number: 947495
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 07/31/2024
• Device Model Number: 2030-6530-1
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: AK1VN2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: 69 YR