MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA UN.FEM HD 40MM R40 16/18; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6519-1-040
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Dr.(b)(6) revised a right hip head/sleeve due to patient instability.He revised from a 40 -2.5 to a +4.Original surgery was (b)(6) 2019 by mako.Update 31/october/2019 wg: rep provided usage sheets from primary and revision procedures and reported that no further information will be released by the hospital or surgeon.Rep also confirmed he was the acting mps for the primary procedure, and that the log and session files are not available from the july procedure.

• Brand Name: DELTA UN.FEM HD 40MM R40 16/18
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9385369
• Report Number: 0002249697-2019-03893
• Device Sequence Number: 479950
• Product Code: JDI
• UDI-Device Identifier: 04546540608444
• UDI-Public: 04546540608444
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• 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): 11/27/2019

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: 05/31/2024
• Device Catalogue Number: 6519-1-040
• Device Lot Number: 72326902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/27/2019
• 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: 72 YR