MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS HIP SEMICONSTRAINED METALCERAMICCERAMICMETAL CEMENTED/UNCEMENTED

Catalog Number	71335550
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on revision the cup was found to be misaligned.No delay, injury or back reported.
Additional Manufacturer Narrative
Updated device is considered the primary part for this event.
Additional Manufacturer Narrative
The associated r3 3 hole acetabular shell, r3 0 deg xlpe acetabular liner and oxinium femoral head were not returned for evaluation.A clinical evaluation noted that no relevant supporting clinical information will be provided.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Our investigation including a review of the manufacturing records for the shell and the liner did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the shell revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• Common Device Name: PROSTHESIS HIP SEMICONSTRAINED METALCERAMICCERAMICMETAL CEMENTED/UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8017280
• Report Number: 1020279-2018-02286
• Device Sequence Number: 11462724
• Product Code: MRA
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2019

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: 02/13/2019
• Device Catalogue Number: 71335550
• Device Lot Number: 09BM11090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 10/03/2018; 10/03/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/01/2018; 04/10/2019; 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 36650/17TM00723.; 71335550/09BM11090.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention