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	12/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was done with the placement of antibiotic impregnated beads.Devices were retained.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, (b)(4) : although it was reported that the patient received an aspiration due to a thigh seroma (document under (b)(4)), no clinical documentation or images has been provided to support these findings.The patient¿s medical history is significant for multiple comorbidities including ccl and cannot be ruled out as possible contributing factors for the infections.The prosthetic joint infection (documented under (b)(4)) is possibly due to a post-surgical complication in the presence of high risk / multiple comorbidities, etc.The i&d and placement of antibiotic impregnated beads (documented under (b)(4)) and the left hip resection arthroplasty and placement of antibiotic spacer (documented under (b)(4)) are likely the result of the unresolved infection.The patient impact beyond the revision itself cannot be concluded.No further medical assessment is possible at this time based on the information provided.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: 8096093
• Report Number: 1020279-2018-02547
• Device Sequence Number: 2016356
• Product Code: MBL
• UDI-Device Identifier: 03596010598035
• UDI-Public: 03596010598035
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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