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	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.Device not returned.
Event or Problem Description
It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.Update via clinician review: [.Preoperative x-rays reveal a cementless acetabular cup with adequate fixation and possible polyethylene wear.The femoral component showed significant osteolysis with probable pathological fracture of the greater trochanter with very little cement fixation in a distal pedestal beneath the femoral implant [.].
Additional Manufacturer Narrative
Correction: investigation conclusion reveals that this reported device is not a suspected cause or contributor to the patient's experience and considered concomitant.The aer decision has been updated accordingly.An event regarding osteolysis, loosening, pathological fracture of a stem involving an other hip screw was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.A clinical review of the provided medical information indicated [.] there is a cementless acetabular component in place.Position and fixation appear satisfactory [.] a full complaint investigation is completed for the stem and liner within the same pi.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15812797
• Report Number: 0002249697-2022-01657
• Device Sequence Number: 7101646
• Product Code: HWC
• UDI-Device Identifier: 07613327036985
• UDI-Public: 07613327036985
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 01/02/2024
• Device Model Number: 2030-6520-1
• Device Catalogue Number: 2030-6520-1
• Device Lot Number: WA25M0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male