MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71331850

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

Patient Problem Inflammation (1932)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 2021, the patient experienced bursitis.This adverse event was treated with a bursal injection on (b)(6) 2023, however it remains ongoing.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided clinical report forms were reviewed; however, they do not provide insight into a clinical root cause of the reported bursitis.Therefore, as of the date of this medical investigation, there were no clinical factors found which would have contributed to the event.It is noted the patient was treated with a bursal injection.The patient impact beyond the reported events cannot be determined.No further medical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers of the femoral head and the shell revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history for the part numbers for the liner and insert over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for or3o¿ dual mobility system revealed in warnings that the patient should be advised to report any pain, decrease in range of motion, swelling, fever, and unusual incidences.Also, the patient should the warned of surgical risks, and made aware of possible adverse effects.A review of the risk management files 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 products and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/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 0 HOLE ACET SHELL 50MM
• 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: 16444304
• MDR Text Key: 310260434
• Report Number: 1020279-2023-00417
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597588
• UDI-Public: 03596010597588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• 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: 03/24/2023

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 Model Number: 71331850
• Device Catalogue Number: 71331850
• Device Lot Number: 21EW09519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 03/24/2023
• Date Device Manufactured: 05/20/2021
• 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: PN: 71342200 / LOT: 21HM11334; PN: 71358202 / LOT: 21AM06190; PN: 71358214 / LOT: A2020506
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 72 KG