MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 40MM; SCREW, FIXATION, BONE

Model Number 2030-6540-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 12/14/2020

Event Type  Injury  

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.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.

Event Description

It was reported that the patient's right hip was revised from a 60mm tritanium hemi cluster shell, 6.5 x 40 mm bone screw, trident 0° poly insert, 36+0 ceramic v40 head to a 64 mm trident ii multihole shell, trident 10° poly insert, and lfit v40 head with three bone screws.Spoke to rep: original diagnosis was shell loosening.However, intra-operatively the shell was reported as well-fixed and difficult to remove.A screw was used to remove the shell.There are no allegations against the revised head and liner.Rep confirmed that no further information would be released by hospital or surgeon and that explants are not available for return.

Event Description

It was reported that the patient's right hip was revised from a 60mm tritanium hemi cluster shell, 6.5 x 40 mm bone screw, trident 0° poly insert, 36+0 ceramic v40 head to a 64 mm trident ii multihole shell, trident 10° poly insert, and lfit v40 head with three bone screws.Spoke to rep: original diagnosis was shell loosening.However, intra-operatively the shell was reported as well-fixed and difficult to remove.A screw was used to remove the shell.There are no allegations against the revised head and liner.Rep confirmed that no further information would be released by hospital or surgeon and that explants are not available for return.

Manufacturer Narrative

Reported event: an event regarding revision involving a cancellous bone screw was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: the event description states: " right hip.Revised.Original diagnosis was shell loosening.Intra-operatively.Shell was well fixed and difficult to remove.A screw was used to remove the shell." 20 x-rays: ap pelvis, lat.Right hip - uncemented tha with 1 screw in acetabulum, reduced, stem nominal, acetabular shell vertical at approx.80 degrees, lucencies in charnley zones 2 & 3.(b)(6) 2019 implant labels: 60 tritanium hemispherical cluster shell, 1 screw, 36/0 degree x3 insert, #8 accoade ii stem, 36/0 v40 biolox head.(b)(6) 2020 implant labels: 64 trident tritanium acetabular shell, 4 screws, 36/10 degrees x3 insert, 36/0 v40 lfit head.No clinical or pmh, no patient demographics, no dated serial x-rays, no operative reports, no examination of explanted components.Based upon the information available for review, nether confirmation of the event description nor preparation of a medical report is possible for this case.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: no clinical or pmh, no patient demographics, no dated serial x-rays, no operative reports, no examination of explanted components.Based upon the information available for review, nether confirmation of the event description nor preparation of a medical report is possible for this case.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 40MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11129715
• MDR Text Key: 225500580
• Report Number: 0002249697-2021-00052
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327037029
• UDI-Public: 07613327037029
• Combination Product (y/n): N
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 2030-6540-1
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: P65306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR