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

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 07/21/2017

Event Type  Injury  

Event Description

It was reported that a patient underwent a second revision surgery due to a mechanical loosening of left internal hip prosthesis.

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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7284273
• MDR Text Key: 100506812
• Report Number: 1020279-2018-00219
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/15/2018
• Device Catalogue Number: 71331852
• Device Lot Number: 08DM15729
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR