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

Catalog Number	2030-6540-1
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	09/12/2012
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient's right hip was revised due to 'loose acetabular socket.' also reported were 'continued pain and mainly groin and lateral pain' shell, screws, liner, and femoral head were revised to a competitor shell, screws, and liner, and a stryker lfit head.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving another hip screw was reported.The event was confirmed via clinician review of the provided medical records.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 by a clinical consultant indicated: "i can confirm that the patient underwent a right total hip arthroplasty on (b)(6) 2011 since i was able to review the operation report.I can also confirm that the patient underwent revision of that right total hip arthroplasty for loosening of the acetabulum on (b)(6) 2012.I can also confirm that the patient was subsequently revised again on (b)(6) 2021 for elevated ion levels and a loose femoral stem since i was able to review that operation report as well.The patient was revised with a competitor acetabular component and a stryker stem with a delta ceramic head.' 'root cause analysis: the root cause of these events cannot be determined with certainty.The causes of early acetabular loosening are multifactorial, including surgical technique in the preparation of the acetabulum, insertion of the acetabular implant, positioning of the implant and impingement.Patient factors such as the quality of the bone should also be considered as well as the patient lifestyle, activity level and bmi.I would not assign any causality for early acetabular component loosening to the implant itself.' -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: it was reported that the patient was revised due to loosening of the shell.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a right total hip arthroplasty on (b)(6) 2011 since i was able to review the operation report.I can also confirm that the patient underwent revision of that right total hip arthroplasty for loosening of the acetabulum on (b)(6) 2012.I can also confirm that the patient was subsequently revised again on (b)(6) 2021 for elevated ion levels and a loose femoral stem since i was able to review that operation report as well.The patient was revised with a competitor acetabular component and a stryker stem with a delta ceramic head.' 'root cause analysis: the root cause of these events cannot be determined with certainty.The causes of early acetabular loosening are multifactorial, including surgical technique in the preparation of the acetabulum, insertion of the acetabular implant, positioning of the implant and impingement.Patient factors such as the quality of the bone should also be considered as well as the patient lifestyle, activity level and bmi.I would not assign any causality for early acetabular component loosening to the implant itself.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, additional pre- and post-operative x-rays 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.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to 'loose acetabular socket.' also reported were 'continued pain and mainly groin and lateral pain.' shell, screws, liner and femoral head were revised to a competitor shell, screws, liner and a stryker lfit head.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 40MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20756053
• Report Number: 0002249697-2024-01613
• Device Sequence Number: 18310599
• Product Code: HWC
• UDI-Device Identifier: 07613327037029
• UDI-Public: 07613327037029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2025

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: 11/30/2015
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: MJN8KR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2010
• 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