MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SCREW, FIXATION, BONE

Catalog Number	2030-6530-1
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
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, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
This pi is for the revised implants.It was reported that the patient's left hip was revised due to the shell shifting and becoming anteverted.Surgeon confirmed shifting by comparing post-op x-rays from primary implant on (b)(6) 2019 and post-op x-rays in (b)(6) 2019.Possible cause or contributor to shell shifting was not reported to rep.A shell, 2 screws, liner, biolox ceramic head and accolade ii stem were revised to a trident tritanium revision shell with 5 screws, an adm/mdm liner construct, lfit v40 metal head, and accolade ii stem.There are no allegations against the liner, head, or stem.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8470310
• Report Number: 0002249697-2019-01492
• Device Sequence Number: 1962389
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: 07/31/2023
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: 2H563X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/01/2019
• 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: 60 YR