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	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving an other hip bone screw was reported.The event was not confirmed.Method and results: product evaluation and results: not preformed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices was 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 event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such product return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's entire left hip construct was revised 16 days after implantation.A 52mm cluster hole shell with 2 screws, 36d liner, 36 -5 ceramic head, and 5x108 stem were revised to a 60mm cluster hole shell with 7 screws, an adm/mdm liner construct, 28 +0 metal head, and a 6x111 stem.Update 31-august-2018: rep reported that patient was revised due to movement of the shell (described as having spun in acetabulum).Surgeon decided to implant a larger shell and revise the rest of the construct to suit.There are no allegations against the liner, head, or stem.

• 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
• MDR Report Key: 7918320
• Report Number: 0002249697-2018-03114
• Device Sequence Number: 1399990
• Product Code: HWC
• UDI-Device Identifier: 07613327037029
• UDI-Public: 07613327037029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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: 03/31/2023
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: KH42DP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/28/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR