MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71335752

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during thr surgery, the r3 20 deg xlpe acet lnr 36mm x 52mm was not locking in the r3 acetabular cup.The procedure was completed, with a significant delay, using a s+n back-up device.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.Based on the information attached in the complaint and tracking number provided the device was not sent to the correct address provided.Shipper was asked if device can be sent to memphis but no response was received, therefore this case will be handled as no product return.The clinical/medical investigation concluded that, as of the date of this medical investigation, supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that to ensure proper locking it should be considered that bone screws must be completely seated in the holes of the shell to allow proper locking for the acetabular component liner, also, prior to seating modular components, surgical debris including blood, bone, tissue, and bone cement must be cleaned from the surfaces.In addition, if the shell is to be cemented in place, remove extraneous cement with a plastic sculps tool to ensure proper locking of the line, avoid repeated assembly and disassembly of the modular components which could compromise the critical locking action of the locking mechanism, this has been identified as instructions for use intraoperative.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 product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include size selected or insertion technique.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 ACET LNR 36MM X 52MM
• Type of Device: 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: 15554261
• MDR Text Key: 301330751
• Report Number: 1020279-2022-04358
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010598332
• UDI-Public: 03596010598332
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 71335752
• Device Catalogue Number: 71335752
• Device Lot Number: 22CM13362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention