MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71332756
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgeon was unable to lock the liner inside acetabular shell during thr surgery, leading to surgical extension.
Additional Manufacturer Narrative
Please see attached file for the results of our investigation.
Additional Manufacturer Narrative
Please see attached file for the results of our investigation.(b)(4).

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X MM56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6845144
• Report Number: 1020279-2017-00710
• Device Sequence Number: 19232665
• Product Code: MBL
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2017

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: 08/01/2025
• Device Catalogue Number: 71332756
• Device Lot Number: 15HM02311
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 08/22/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/20/2017; 11/21/2017
• 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