MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336456
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that, after a thr had been performed on an unknow date, the patient experienced an infection.A revision surgery was performed on (b)(6) 2024 to address this adverse event.Patient's current health status is unknown.
Additional 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, in the absence of the requested medical documentation, clinical factors which could have contributed to the reported infection could not be definitively concluded, and a causal relationship between the smith and nephew¿s device and the reported infection could not be established with the limited information provided.According to the report, the patient underwent a revision on 3-27-2024, to treat this adverse event.The impact to the patient beyond the reported infection and subsequent revision cannot be determined since the outcome of the patient is unknown.Should any additional relevant medical information be provided, this case would be re-assessed.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 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 device.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 in potential complications associated with total hip arthroplasty surgery, primary or revision section.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 product and event.A review of the sterilization records revealed that 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 loss of sterility during procedure, post-operative healing issue, 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.

• Brand Name: REF THREE HOLE SHELL 56MM
• Common Device Name: 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: 19142493
• Report Number: 1020279-2024-00781
• Device Sequence Number: 7834024
• Product Code: MBL
• UDI-Device Identifier: 03596010454379
• UDI-Public: 03596010454379
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/06/2024

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 Expiration Date: 05/23/2016
• Device Catalogue Number: 71336456
• Device Lot Number: 06EM03301
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/06/2024
• 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: 71312362/CPCS COCR PRIM SO 12/14 SZ 2; 71332530/REF SPHER HEAD SCREW 30MM; 71332530/REF SPHER HEAD SCREW 30MM; 71333345/REF XLPE 36 20 DEG 54-56 F; 71343603/OXINIUM FEM HD 12/14 36 MM -3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown