MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED

Model Number 71335552

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperplasia (1906); Metal Related Pathology (4530)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-2022-00103691-1.

Event Description

It was reported that, after right r3-tha was performed on (b)(6) 2010 due to right severe osteoarthritis, the patient experienced degenerative changes and mild synovial hyperplasia.This adverse event was treated with a revisions surgery on (b)(6) 2021.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the metallosis.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported metallosis cannot confirmed.However, it is unknown if the retroverted acetabular component led to accelerated wear and the reported metallosis.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 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 hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.It is unknown if the retroverted acetabular component led to accelerated wear and the reported metallosis.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 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 damaged product, implant corrosion or wear.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

Event Description

It was reported that, after right r3-tha was performed on (b)(6) 2010 due to right severe osteoarthritis, the patient experienced degenerative changes and mild synovial hyperplasia.When the acetabular component was retroverted, metallosis was confirmed.This adverse event was treated with a revisions surgery on (b)(6) 2021.Patient's current health status is unknown.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED
• 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: 14466161
• MDR Text Key: 292502248
• Report Number: 1020279-2022-02483
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2020
• Device Model Number: 71335552
• Device Catalogue Number: 71335552
• Device Lot Number: 10HM05219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female