MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71357106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had first stage revision hip arthroplasty due to infected thr on (b)(6) 2018 by dr.(b)(6) at wollongong private.Primary procedure was done at wollongong private by dr.Stackpool on (b)(6) 2018.
Additional Manufacturer Narrative
The associated complaint devices were not returned.No relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of complaint history on the listed parts and their corresponding batches revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489550
• Report Number: 1020279-2018-00876
• Device Sequence Number: 10799201
• Product Code: JDI
• UDI-Device Identifier: 03596010559616
• UDI-Public: 03596010559616
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2018

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: 04/06/2026
• Device Catalogue Number: 71357106
• Device Lot Number: 16DM05960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018; 04/11/2018
• Initial Report FDA Received Date: 05/06/2018
• Supplement Report FDA Received Date: 05/06/2018; 11/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention