MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 36MM X 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338564
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision on the right thr (b)(6) 2018.Presents with acute infection of right thr.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it was reported that a revision surgery was performed due to acute infection.Multiple unsuccessful requests have been made to obtain relevant supporting medical information to assist with a clinical investigation.Additionally, 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 part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, 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: R3 20 DEG +4 XLPE ACET LNR 36MM X 64MM
• 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: 7702433
• Report Number: 1020279-2018-01323
• Device Sequence Number: 2643357
• Product Code: MBL
• UDI-Device Identifier: 03596010598776
• UDI-Public: 03596010598776
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2018

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: 06/21/2026
• Device Catalogue Number: 71338564
• Device Lot Number: 16FM18667
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/08/2018
• 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: 3849717696581/7011147037
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR