MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM46; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335546
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent hip revision surgery due to infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation included a review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that there is no report of any lab tests confirming an infection.There were three attempts to obtain clinical/medical records to adequately perform a clinical assessment, however nothing has been provided.The patient impact beyond the revision surgery cannot be determined, as there is no report of the patient¿s current condition, infection status or how the procedure was tolerated.No further clinical assessment is warranted.The investigation noted that the listed parts were sterilized according to sterilization release documentation from quality control.Without the return of the actual products 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 the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL MM46
• 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: 7003315
• Report Number: 1020279-2017-00976
• Device Sequence Number: 11225333
• Product Code: MBL
• UDI-Device Identifier: 03596010598219
• UDI-Public: 03596010598219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: Health Professional
• Device Catalogue Number: 71335546
• Device Lot Number: 17BM10856
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 06/18/2018
• 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: R3 20DEG XLPE ACET LNR 28X46MM/71334946/16BM14130; REF SPHER HEAD SCREW 30MM/71332530/16KB01732; REF THREADED HOLE COVER7/71336500/17CM17525
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention