MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 40MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338680
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to periprosthetic infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the reported loosening in the 1st revision, and elevated cobalt levels in the 2nd revision, may be consistent with findings associated with metal debris.The need for the subsequent revisions cannot rule out the patient¿s ongoing/continual presence of strep viridans as a contributing factor.Without supporting imaging, and/or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be concluded, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined.No further clinical assessment is warranted at this time.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: R3 0 DEG XLPE ACET LNR 40MM X 58MM
• 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: 8643153
• Report Number: 1020279-2019-02048
• Device Sequence Number: 380913
• Product Code: MBL
• UDI-Device Identifier: 00885556113240
• UDI-Public: 00885556113240
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 04/11/2023
• Device Catalogue Number: 71338680
• Device Lot Number: 13LM04604
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/26/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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