MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESISHIPSMICONSTRAINDUNCMNTDETALPOLYMRPOROUS

Catalog Number 71335558

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

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Sepsis (2067); Metal Related Pathology (4530)

Event Date 10/23/2020

Event Type  Injury  

Event Description

*us legal mdl* it was reported that a revision surgery was performed on the patient right hip on (b)(6) 2020.The two stage revision was performed due to infection of prosthetic total hip joint, sepsis, group g streptococcus, and a lower extremity fracture.The patient has undergone multiple ongoing surgeries with continuous infections and multiple spacer replacements and spacer exchanges.No conclusive second stage part of the revision procedure has been performed yet.The patient outcome is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the intraoperative findings of dark, gelatinous tissue, murky thick fluid, corrosion at the taper, loosening of the cup, and positive cultures for group g streptococcus are consistent with the reported infection and trunnionosis.However, based on the information provided, the root cause of the clinical reactions cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.It cannot be confirmed that the reported events are associated with a mal-performance of the implant.The patient impact beyond that which has already been reported cannot be determined.No further clinical assessment is warranted at this time.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 additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include contamination, patient reaction, or post-operative healing issue, friction, joint tightness, excessive forces, abnormal loading, damaged product or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

Event Description

It was reported that a first stage revision surgery was performed on the patient right hip on (b)(6) 2019.The two-stage revision was performed due to infection of prosthetic total hip joint, sepsis, group g streptococcus, and metallosis consistent tissue around the implants.During the first stage revision surgery, when attempted to extract the stem the femur was fractured in multiple places, and repair with a plate and wires.Also, a small amount of corrosion was noted at the head neck junction.After the first stage revision surgery, the patient underwent multiple ongoing surgeries with continuous infections and multiple washouts and vac placements.The conclusive second stage revision surgery was performed on (b)(6) 2019.After this, the patient had 2 additional revision surgeries due to mechanical failure of the implants, but no smith and nephew implants were involved.The patient outcome is unknown.

Manufacturer Narrative

D4: catalog number, expiration date, udi and lot number added.D10: concomitant part added.H6: additional clinical codes added.(b)(4).B4: event description updated.D1: brand name updated.

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• Type of Device: PROSTHESISHIPSMICONSTRAINDUNCMNTDETALPOLYMRPOROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12075269
• MDR Text Key: 258629760
• Report Number: 1020279-2021-05452
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

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 Expiration Date: 03/23/2019
• Device Catalogue Number: 71335558
• Device Lot Number: 09CM19410
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/02/2021; 09/10/2021
• Supplement Dates FDA Received: 09/01/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74222100 MODULAR SLEEVE -4MM 12/14
• Patient Outcome(s): Hospitalization; Other; Required Intervention