MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331952

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

Patient Problem Muscle/Tendon Damage (4532)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2021, the patient experienced an abductor tendon tear.This adverse event was solved by a surgical repair on the left hip on (b)(6) 2023, to address the torn abductor.Patient's current health status is recovered.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported abductor tendon tear could not be concluded.However, we are unable to rule out the patient¿s medical history as a contributing factor to the reported event.Furthermore, it cannot be concluded there was a mal performance of the implant or an implant failure.The patient impact is determined to be the subsequent procedure to repair the abductor tear.No further patient impact is anticipated as it was noted that the event was resolved with the procedure.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 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.A review of the instructions for use documents for total hip systems revealed that postoperative warnings, precautions, and patient care instructions presented by the physician are extremely important.Gradual weight bearing begins after surgery in ordinary total hip arthroplasty procedures.However, with the trochanter osteotomy or certain complex cases, the weight bearing status should be individualized with the non or partial weight bearing period extended.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury or patient condition.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 3 HOLE HA CTD ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 19085159
• MDR Text Key: 339877295
• Report Number: 1020279-2024-00728
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597748
• UDI-Public: 3596010597748
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331952
• Device Lot Number: 21HM07331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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: 71312362/21HM09059/CPCS COCR PRIM SO 12/14 SZ 2; 71342200/21CM12136/OXINIUM FEM HD 12/14 22 MM +0; 71358203/20KM15049/OR3O DUAL MOBILITY LINER 40/52; 71358216/A20113660/OR3O DM XLPE INSERT 22/40
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 98 KG