MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 40MM ID X 56OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71338687
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Fever (1858); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
*eu legal* it was reported that, after a thr performed on (b)(6) 2014, the plaintiff experienced high fever and high levels of cocr in blood.A two-stage revision surgery was performed to treat these adverse events; on (b)(6) 2020 the devices were explanted, and a cement spacer was applied, leaving the plaintiff with no mobility.Then on (b)(6) 2020 the revision surgery was completed with the implantation of new prosthesis.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to material in use or patient reaction.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE LNR 40MM ID X 56OD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11907560
• Report Number: 1020279-2021-04813
• Device Sequence Number: 4381192
• Product Code: MBL
• UDI-Device Identifier: 00885556113189
• UDI-Public: 00885556113189
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: 71338687
• Device Catalogue Number: 71338687
• Device Lot Number: 11FM05777
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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