MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71332762
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aspiration of the left hip was performed due to a thigh seroma and prosthetic joint infection.Open irrigation and debridement was done.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, (b)(4) details regarding the patient¿s weight-bearing status, bone quality, and fall/trauma history have not been provided.Although, evidence of metallosis was reported during the revision no supporting clinical documentation has been provided for review.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported component loosening and pain cannot be determined however, the reported articulation between the femoral neck and the liner reported in the intraoperative findings could have been a contributing factor or a result of the loosening which caused the pain.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.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.We consider this investigation closed.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 62MM
• 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: 8095923
• Report Number: 1020279-2018-02546
• Device Sequence Number: 19519197
• Product Code: MBL
• UDI-Device Identifier: 03596010598035
• UDI-Public: 03596010598035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 09/06/2026
• Device Catalogue Number: 71332762
• Device Lot Number: 16JM02336
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 05/30/2019
• 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
• Patient Age: 60 YR