MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 52MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71331752

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/28/2012

Event Type  Injury  

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2012, the patient experienced unexplained hip pain when he walks, little exercise tolerance.This adverse event was checked by a clinical study on (b)(6) 2023, and was treated via surgery.Patient's current outcome is resolved.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the devices were not returned for evaluation.The clinical/medical investigation concluded that, the clinical study documents were reviewed.However, it did not provide any clinical insight into the reported unexplained hip pain with walking and little exercise tolerance.Therefore, there were no clinical factors found which would have contributed to the reported pain with walking and little exercise tolerance.Per complaint details, the pain was treated and resolved with a surgical procedure.No further clinical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Device batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the liner and shell, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history of the previous 12 months revealed a similar events for the head and modular neck, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history for the previous 12 months did not reveal similar events for the stem.A review of the instructions for use documents for total hip systems revealed that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants, this has been identified as warnings and precautions.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or patient condition.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: R3 36MM ID INTL DLT CER LNR 52MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 16748727
• MDR Text Key: 313388102
• Report Number: 1020279-2023-00837
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331752
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/16/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71331852/R3 0 HOLE ACET SHELL 52MM; 71352112/HIGH OFFSET NEUTRAL MODULAR NECK; 71352501/SMF STEM WITH STIKTITE SZ 1; 76539165/DELTA HEAD 36MM 12/14 SHORT +0MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 83 KG