MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 60MM; PROSTHESIS,HIP,SEMICONSTRAINED,METALPOLYMER,POROUS

Model Number	71335760
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a subsequent right hip revision surgery due to septic hip.Liner and femoral head exchanged.
Additional Manufacturer Narrative
The devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2013 and 2017.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of complaint history did not reveal additional complaints for the listed batches.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Product was sterilized according to sterilization release documentation from quality control.Our clinical/medical team noted: the infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The reported symptoms of marked soft tissue swelling , induration and erythema along with synovial fluid cultures positive for 4+ staphylococcus lugdunensis, may be consistent of synovitis.However, without the supporting pathology results, imaging and/or the analysis of the explanted components the source of reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 60MM
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METALPOLYMER,POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9610966
• Report Number: 1020279-2020-00351
• Device Sequence Number: 2669394
• Product Code: MBL
• UDI-Device Identifier: 03596010598370
• UDI-Public: 03596010598370
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: Lay User/Patient
• Device Expiration Date: 01/22/2023
• Device Model Number: 71335760
• Device Catalogue Number: 71335760
• Device Lot Number: 13AM13298
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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: 74 YR