MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DUAL MOBILITY LINER 44/58; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUS UNCEMENTED

Model Number	71358206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on june 22nd a surgeon performed an revision procedure utilizing an or3o liner in a redapt modular acetabular shell.On june 23rd the patient dislocated and additional revision procedure to be performed.On june 25th the surgeon performed additional revision surgery altering the cup inclination to 45 degrees and utilized a new or3o dual mobility liner.
Additional Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: OR3O DUAL MOBILITY LINER 44/58
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10344732
• Report Number: 1020279-2020-03578
• Device Sequence Number: 11504275
• Product Code: LPH
• UDI-Device Identifier: 00885556712276
• UDI-Public: 00885556712276
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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 Model Number: 71358206
• Device Catalogue Number: 71358206
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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: Hospitalization; Required Intervention