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

Model Number 71335552

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

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Injury (2348); Osteolysis (2377); Post Operative Wound Infection (2446)

Event Date 06/04/2018

Event Type  Injury  

Event Description

It was reported that two-stages revision surgery was performed two years after primary procedure due to loosening and infection with placement of antibiotic spacers.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the root cause for the revision was as stated the ¿loosening of the acetabular component¿ and the infection.It is unclear which came first the infection or the loosening but as the infection was 2 years post primary its considered exogenous in nature and not related to the device.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551907
• MDR Text Key: 207492732
• Report Number: 1020279-2020-04659
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71335552
• Device Catalogue Number: 71335552
• Device Lot Number: 16BW11879
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention