MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 35MM; SCREW, FIXATION, BONE

Model Number	2030-6535-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the 2017 hip revision of unknown reason.Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent revision right total hip arthroplasty on (b)(6) 2017, where she was implanted with a stryker hip system.Its further alleged that the patients right hip had to be revised again on (b)(6) 2018 due to acetabular component loosening.Update on 22-feb-2022 per clinician review: on (b)(6) 2017, a 'right revision total hip arthroplasty' was performed for a 'pre- and post-operative diagnosis of aseptic loosening right total hip arthroplasty'.The operative report notes, acetabular component was grossly loose, screw was broken, distal end of screw, remained deep in the bone.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a hip screw was reported.The event was confirmed via clinician review.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 information by a clinical consultant indicated: no x-rays are available for the period between (b)(6) 2015 and (b)(6) 2017 when a loose acetabular component was visible.No dated serial x-rays of the right total hip arthroplasty are available.There is no documented follow-up after (b)(6) 2018 and no examination of the explanted components.There is no primary right total hip arthroplasty operative report from the (b)(6) 2014 surgery.It was not clear if the initial acetabular component was properly sized and positioned, which may have contributed to the initial acetabular post-traumatic loosening.The history of popping and possible ,metabolic and medication factors may also have contributed.When a larger revision component was placed on (b)(6) 2017 it loosened in sixteen days and once again was revised to a larger component with multiple screws.There is no evidence these failures of biologic fixation of the acetabular component were related to factors associated with acetabular component design, manufacturing or materials.Product history review: review of the device history records indicate 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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, dated serial x-rays and the primary operative report are needed to complete the investigation for determining root cause.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.Device not returned.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 35MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13796000
• Report Number: 0002249697-2022-00408
• Device Sequence Number: 5063087
• Product Code: HWC
• UDI-Device Identifier: 07613327037012
• UDI-Public: 07613327037012
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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
• Device Expiration Date: 08/31/2019
• Device Model Number: 2030-6535-1
• Device Catalogue Number: 2030-6535-1
• Device Lot Number: MNL51T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 115 KG