MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71335562
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Drug Resistant Bacterial Infection (4553); Medical device site infection (4845)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that after undergoing a thr on (b)(6) 2024, patient experienced infection.This adverse event was addressed by performing a revision surgery on (b)(6) 2024, during which the r3 3 hole acet shell 62mm, the r3 20 deg xlpe acet lnr 36mm x 62mm, the biolox delta ce ball head 12/14 36s and the polarstem stem std ti/ha 8 non cem were exchanged.Patient's current health status is fine.
Additional Manufacturer Narrative
Additional information: h6 (type of investigation), h10 (roi).H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that results noted that the three cultures taken (1 soft parts / 1 acetabulum / 1 femur), were 3/3 growth of s.Aureus (methicillin-resistant staphylococcus aureus).While pre and post x-ray images were provided for review they do not aid in determining the root cause for the reported infection.Based on the information provided the reported infection experienced by the patient was due to bacterial (methicillin-resistant staphylococcus aureus) infection.This type of infection is a result of the procedure itself and not a malperformance of the smith and nephew device.Bacterial contamination of the wound can occur during surgery or later due to the deterioration of skin barriers during wound care.The patient impact is determined to be the revision surgery and post-operative convalescence period.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the shell, the liner and the head, 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.For the stem, a review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection has been identified as a potential complication associated with total hip arthroplasty surgery, primary or revision.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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.H6 (health effect - clinical code, health effect - impact code and investigation conclusions).

• Brand Name: R3 3 HOLE ACET SHELL 62MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 20802998
• Report Number: 1020279-2024-02496
• Device Sequence Number: 13130062
• Product Code: LPH
• UDI-Device Identifier: 03596010598295
• UDI-Public: 3596010598295
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71335562
• Device Lot Number: 23LW10603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOLOX DELTA CE BALLHD 12/1436S:75007448,C2319632; POLARSTEM STM STD TI/HANON-CEM:75100471,B1810511; R3 20 DEG XLP ACT LNR 36X62:71335762,22JM15189
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male