MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71332754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
(b)(6); ae: 01 infection.It was reported that, after a tha surgery performed on (b)(6) 2019, due to the developed of periprosthetic joint infection a revision surgery was performed on (b)(6) 2019 for an irrigation debridement and the extraction of the oxinium femoral head 12/14 taper 36 mm -3 (case (b)(4)) and the r3 0 degree xlpe acetabular liner 36mm id x od 54mm (case (b)(4)).This adverse event was resolved and patient is recovered.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.It has been confirmed that the same event has been already reported under report number (b)(4) (our internal reference number (b)(4)).We conclude that the event will be investigated under this last complaint mentioned.Therefore, this report will be closed as duplicate.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal reference number: (b)(4).

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12533982
• Report Number: 1020279-2021-07179
• Device Sequence Number: 1414184
• Product Code: JDI
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71332754
• Device Catalogue Number: 71332754
• Device Lot Number: 18BM21223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 10/22/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTICS; ANTIBIOTICS
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG