MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335556
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to device instability.
Additional Manufacturer Narrative
The associated r3 3 hole acetabular shell, r3 20 deg acetabular liner, smf fixed neck stiktite coated stem and oxinium head were not made available for evaluation.Therefore a thorough product inspection could not be performed.However, device details were provided.Thus, a review of the manufacturing records and complaint history was performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, our investigation of this report is inconclusive.Our clinical evaluation noted that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no clinical assessment can be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation 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 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: 8279030
• Report Number: 1020279-2019-00293
• Device Sequence Number: 1527990
• Product Code: MBL
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (Y/N): N
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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 Catalogue Number: 71335556
• Device Lot Number: 17CW00077
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 64 YR