MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CMNTD OR UNCMNTD

Catalog Number	71331852
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a second revision surgery due to a mechanical loosening of left internal hip prosthesis.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.No valid information for clinical investigation, therefore no further medical assessment can be rendered at this time.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.Without the return of the actual product involved information, our investigation of this report is inconclusive.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that only one smith and nephew device was explanted on this revision surgery which is already captured under report 1020279-2018-00220 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: R3 0 HOLE ACET SHELL 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7284273
• Report Number: 1020279-2018-00219
• Device Sequence Number: 16176749
• Product Code: MRA
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (Y/N): N
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2018

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: No Information
• Device Expiration Date: 04/15/2018
• Device Catalogue Number: 71331852
• Device Lot Number: 08DM15729
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018; 09/12/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 05/24/2018; 10/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR