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

Model Number	71338667
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to painful and loose right total hip arthroplasty.Fully loose acetabular cup.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms all medical documents provided were reviewed.However, when notification by the legal team has been made that all medical documentation has been provided this complaint will be re-evaluated and a thorough medical assessment rendered.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Some potential probable causes of this event could include an improper surgical technique or device selection.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 MULTI HOLE ACETABULAR 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: 9083547
• Report Number: 1020279-2019-03431
• Device Sequence Number: 2883202
• Product Code: MBL
• UDI-Device Identifier: 00885556021934
• UDI-Public: 00885556021934
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 11/02/2024
• Device Model Number: 71338667
• Device Catalogue Number: 71338667
• Device Lot Number: 14LM02767
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 03/25/2020
• 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; Required Intervention
• Patient Age: 57 YR