MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	7030-6530
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured, and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported that the screw penetrated through the acetabular shell during surgery.
Additional Manufacturer Narrative
Reported event: an event regarding screw migration involving a screw was reported.The event was confirmed by medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: re pi which is from canada and represents a male patient whose date of implantation is listed as (b)(6) 2020.The event description states: "screw penetrated through the acetabular shell during surgery." undated implant labels: 52 trident ii ha cluster hole acetabular shell, 2 6.5/30mm low profile hex screws.1 label circled with red line, 36/10 degree x3 polyethylene insert, #5 accolade ii stem, 36/0 v40 biolox head.Undated x-ray: ap right hip: reduced, uncemented tha, 2 screws in acetabulum 1 of which is through the shell and in the pelvis, distal and lateral stem not visualized.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no follow-up or description of clinical symptoms or problems.While the x-ray appears to confirm the event description, insufficient information is available to create a medical report for this case.Product history review: review of the device history records indicate 500 devices were manufactured and accepted into final stock between the (b)(6) and the (b)(6) 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, pathology reports, pre- and post-operative x-rays and 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.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 screw penetrated through the acetabular shell during surgery.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 30MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10990221
• Report Number: 0002249697-2020-02641
• Device Sequence Number: 18989879
• Product Code: LPH
• UDI-Device Identifier: 07613327345063
• UDI-Public: 07613327345063
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 7030-6530
• Device Catalogue Number: 7030-6530
• Device Lot Number: 339
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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: Other