MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71331856
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the liner would not lock into the shell resulting in a surgical delay greater than 30 minutes.
Additional Manufacturer Narrative
[(b)(4)].

• Brand Name: R3 0 HOLE ACET SHELL 56MM
• 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: 6849564
• Report Number: 1020279-2017-00721
• Device Sequence Number: 44570
• Product Code: MBL
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 07/24/2017
• Device Catalogue Number: 71331856
• Device Lot Number: 17GM14805
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 02/13/2018
• 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; Other
• Patient Age: 71 YR