MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SS 12/14 TPR FEM HD 32MM +0; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71293200

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

Patient Problems Ulcer (2274); Joint Dislocation (2374); Post Operative Wound Infection (2446)

Event Date 11/06/2019

Event Type  Death  

Manufacturer Narrative

Internal complaint reference: (b)(4).Postal code: (b)(4).

Event Description

** legal case ** it was reported that 3 months after having a thr, the patient suffered from a dislocation and underwent a closed reduction on (b)(6) 2019.Due to another dislocation, the patient had an open reduction on (b)(6) 2019, where the femoral head was replaced.As reported, the patient underwent recurrent surgeries and died from post-surgical infection on an unspecified date.

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that 3 months after having a thr, the patient suffered from a dislocation and underwent a closed reduction on (b)(6) 2019.Due to another dislocation, the patient had an open reduction on (b)(6) 2019, where the femoral head was replaced.Because of the recurrent dislocations, the patient had to stay in bed for about a year and developed metal pressure and diabetes.As reported, the patient developed diabetic foot ulcer and passed away from an infection on (b)(6) 2020.

Event Description

It was reported that, 3 months after having a thr, the patient suffered from a dislocation and underwent a closed reduction on (b)(6) 2019.Due to another dislocation, the patient had an open reduction on (b)(6) 2019, where the femoral head was replaced.Because of these past recurrent dislocations before the revision surgery, the patient had to stay in bed for about a year and developed metal pressure and diabetes.As reported in the final operation, the patient developed diabetic foot ulcer and passed away from an infection on (b)(6) 2020.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, but the pictures were reviewed, and the reported dislocation was confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously evaluated and the anticipated risk level is still adequate.A review of the instruction documents concluded that the instructions for use of the product includes required indications to help mitigate anticipated adverse events.A review of the sterilization records revealed the batch was sterilized within normal parameters 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.The clinical/medical investigation concluded that, the clinical root cause of the reported dislocations cannot be confirmed.It cannot be concluded the dislocations, reductions and subsequent revision were associated with a mal performance of the implant.It was reported the patient¿s death was related to a diabetic foot ulcer and infection.There is no evidence the diabetes, diabetic foot ulcer, infection and subsequent death are related to implant.At smith and nephew, the wellbeing of our customers as well as the compliance with the authorities are extremely important, therefore, our devices and surgical techniques are subjected through numerous tests, validations in clinical studies and trainings before being released to the market.However, patients may experience adverse effects and complications depending on their condition, age, physical activity, among other aspects.Dislocation is a potential postoperative complication in hip surgeries.Probable causes for this incident could include but are not limited to alignment, surgical technique, size of the device used, patient condition or abnormal loading of limb.Infection, also a possible risk involved in surgeries, includes contamination, patient reaction or post-operative healing issue as probable causes.Due to the need of revision surgeries, the contribution of the device to the reported dislocation was corroborated, however, the contribution of the device to the reported infection and diabetes foot ulcer could not be corroborated.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: SS 12/14 TPR FEM HD 32MM +0
• 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: 12699006
• MDR Text Key: 278406600
• Report Number: 1020279-2021-07675
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

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: 71293200
• Device Lot Number: 18FT05879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 12/12/2021; 02/04/2022
• Supplement Dates FDA Received: 12/14/2021; 02/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2018
• 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: 71312360-CPCS COCR PRI SO 12/14 SZ 0; 71312360-CPCS COCR PRI SO 12/14 SZ 0; 71312360/CPCS COCR PRI SO 12/14 SZ 0; 71312410 - CPCS DIST CENT SZ 10MM; 71312410/CPCS DIST CENT SZ 10MM; 71332525-REF SPHER HEAD SCREW 25MM; 71332525-REF SPHER HEAD SCREW 25MM; 71332525/REF SPHER HEAD SCREW 25MM; 71332530-REF SPHER HEAD SCREW 30MM; 71332530-REF SPHER HEAD SCREW 30MM; 71332530/REF SPHER HEAD SCREW 30MM; 71335558-R3 3 HOLE ACET SHELL 58MM; 71335558-R3 3 HOLE ACET SHELL 58MM; 71335558/R3 3 HOLE ACET SHELL 58MM; 71339558-R3 0 DEG XLPE ACET LNR 32MM X 58MM; 71339558-R3 0 DEG XLPE ACET LNR 32MM X 58MM; 71339558/R3 0 DEG XLPE ACET LNR 32MM X 58MM; 71312360-CPCS COCR PRI SO 12/14 SZ 0; 71332525-REF SPHER HEAD SCREW 25MM; 71332530-REF SPHER HEAD SCREW 30MM; 71335558-R3 3 HOLE ACET SHELL 58MM; 71339558-R3 0 DEG XLPE ACET LNR 32MM X 58MM
• Patient Outcome(s): Hospitalization; Other; Death
• Patient Age: 51 YR
• Patient Sex: Male