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

Catalog Number	71331852
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that part broke inside the patient and needed to be removed.
Additional 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
• 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: 8076576
• Report Number: 1020279-2018-02512
• Device Sequence Number: 1500512
• Product Code: MBL
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 09/06/2021
• Device Catalogue Number: 71331852
• Device Lot Number: 11JM04247
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 09/23/2019
• 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: Other; Required Intervention