MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331852

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 10/26/2018

Event Type  Injury  

Event Description

It was reported that part broke inside the patient and needed to be removed.

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved our investigation cannot proceed.The medical investigation concluded that all documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 0 HOLE ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8076576
• MDR Text Key: 127338198
• Report Number: 1020279-2018-02512
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2021
• Device Catalogue Number: 71331852
• Device Lot Number: 11JM04247
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention