MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +8; PRSTHSIS,HIP,SMI-CNSTRND,MTAL/CRAMIC/PLYMR,CMNTDRNN-POROUS, UNCEMENTED

Catalog Number	71342808
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had right hip prosthesis infection after surgery.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and an infection occurring approximately 9 years post op is likely of a hematogenous nature.There is no evidence that our devices contributed to the reported infection.It was reported the patient was also being treated for pneumonia and was prescribed septra.The infection is reportedly resolved.No further clinical assessment is warranted based on the information provided.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.

• Brand Name: OXINIUM FEM HD 12/14 28MM +8
• Common Device Name: PRSTHSIS,HIP,SMI-CNSTRND,MTAL/CRAMIC/PLYMR,CMNTDRNN-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8530139
• Report Number: 1020279-2019-01603
• Device Sequence Number: 1516028
• Product Code: LZO
• UDI-Device Identifier: 03596010474179
• UDI-Public: 03596010474179
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• 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): 10/28/2019

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: 01/31/2022
• Device Catalogue Number: 71342808
• Device Lot Number: 12BM02544
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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: PART NUMBER: 74222300.LOT NUMBER: 07EW11734.
• Outcome Attributed to Adverse Event: Other