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

Catalog Number	71332754
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr revision surgery, intraoperatively it was noticed that there was no proper exchange for the reflection system.Due to a misunderstanding in the customer's order placed with sn, inserts were delivered for the r3 system and not for the reflection system for this surgery.A proper exchange implant was delivered from another hospital during the surgery, the duration of the surgery was extended.The surgery was successfully completed.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the clinical/medical investigation concluded that the material order form and the admission report have r3 cup noted with a reflection part number and lot number (71743254, 12gm16411); therefore, procedural variances cannot be ruled out as contributing factors to the ordering, delivery and attempt of implantation of the r3 xlpe insert.The patient impact is the 50-minute surgical delay.Given the nature of the reported issue, there is no reason to suspect a manufacturing deficiency.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.No similar logistic issues have been reported in the german territory for the past 12 months.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this event.This issue was escalated through our quality process to investigate the delivery of wrong implant after misinterpretation of customer order.The departments involved were trained to double check in the system the part numbers in the orders.Should 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.Corrected data: b5 (narrative updated),.
Event or Problem Description
It was reported that, during a thr revision surgery, intraoperatively it was noticed that there was no proper exchange for the reflection system.Due to a misunderstanding in the customer's order placed with sn, inserts were delivered for the r3 system and not for the reflection system for this surgery.A proper exchange implant was delivered from another hospital during the surgery.The duration of the surgery was extended more than 30 min.The surgery was successfully completed.

• 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: 18816432
• Report Number: 1020279-2024-00462
• Device Sequence Number: 12857851
• Product Code: JDI
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71332754
• Device Lot Number: 23GM05162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown