MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED

Catalog Number	71335560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had an infection, so we removed the implant and put in an antibiotic spacer.
Additional Manufacturer Narrative
The associated r3 3-hole shell was not returned for evaluation.A clinical evaluation noted that no relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, per complaint, the infection was reported as the root cause for the revision.The patient impact beyond the revision/placement of the antibiotic spacer cannot be determined.No further medical assessment is warranted at this time.The device was manufactured in 2010.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our investigation including a review of review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Product was sterilized according to sterilization release documentation from quality control.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.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7653905
• Report Number: 1020279-2018-01254
• Device Sequence Number: 11175751
• Product Code: MRA
• UDI-Device Identifier: 03596010598288
• UDI-Public: 03596010598288
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: Lay User/Patient
• Device Catalogue Number: 71335560
• Device Lot Number: 10M11209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/30/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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