MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number	OR71331858
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented with left hip arthroplasty infection.The patient underwent a left hip arthrotomy for removal of prosthesis and insertion of cement spacer.
Additional Manufacturer Narrative
The associated devices were not returned for evaluation.Due to limited relevant information in the medical records, a definitive root cause for the chronic recurrent infection and subsequent revisions cannot be determined.The patient¿s history of end-stage avn prior to the initial cocr implantation, followed by recurrent infections after the implant removal cannot be eliminated as contributing factors.The patient¿s current status remains unknown.No further medical assessment can be rendered.A review of manufacturing records did not reveal any manufacturing deviations that could have contributed to this issue.A review of sterilization documentation found that all devices were sterilized according to quality processes.We have not had any previous complaints for the associated batches/failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information is received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Concomitant medical product: (b)(4) is not related to this complaint.

• Brand Name: R3 0 HOLE ACET SHELL 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6770013
• Report Number: 1020279-2017-00588
• Device Sequence Number: 10817982
• Product Code: MRA
• UDI-Device Identifier: 03596010597625
• UDI-Public: 03596010597625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2018

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 Expiration Date: 07/07/2018
• Device Catalogue Number: OR71331858
• Device Lot Number: 08FM11989B
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017; 07/06/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 04/13/2018; 05/04/2018
• 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: 71336500/09GM15900; 71356106/19KM11295; 74222200/19BW21807; UNKNOWN HEAD; UNKNOWN LINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR