MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71332756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed in which a spectron/r3 system was implanted, the patient experienced pain and symptoms of infection, which resulted in wound breakdown.The pathology revealed that a gentamycin-resistant organism was present from previous tests.The first-stage revision surgery was perform to treat the infection: fluid and tissue samples were taken out and the retrieved implants were sent for sonication pathology testing.The cement spacer was placed in situ.The second-stage revision surgery will be conducted after the long-term antibiotic treatment that is necessary to address the infection.
Additional Manufacturer Narrative
It was reported that after a thr with specton system was implanted, the patient experienced pain and symptoms of infection which resulted in wound breakdown.The first-stage revision surgery was perform to treat the infection.The associated device, used in treatment, was not returned for evaluation.Thus the product analysis could not be performed.As device information was not made available, device history record and sterilization documentation cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.This reported failure has been identified in the instructions for use and risk management files.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X MM56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10076074
• Report Number: 1020279-2020-01803
• Device Sequence Number: 19672529
• Product Code: JDI
• UDI-Device Identifier: 03596010598004
• UDI-Public: 3596010598004
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: Health Professional
• Device Catalogue Number: 71332756
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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; Life Threatening; Required Intervention