MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28ID 20 DEG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71742854
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a surgery was performed, the patient experienced instability, scans indicated liner wear.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a ref lnr 28id 20 deg sz f and a cocr 12/14 fem head 28 +0 were exchanged.The liner that was explanted displayed eccentric wear due to its age and material.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).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.
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, patient had a revision (b)(6) 2023, it is noted scans indicated liner wear.However, as of the date of this medical investigation, supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the reported revision cannot be determined with the limited information provided.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 wear of the polyethylene, metal, and ceramic articulating surfaces of acetabular components may occur.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis and lead to earlier revision surgery to replace the worn prosthetic components, this has been identified as adverse events in primary and revision surgery.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 specifications at the time of manufacture.Factors that could contribute to the reported event include friction or joint tightness.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: REF LNR 28ID 20 DEG SZ F
• 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: 16773443
• Report Number: 1020279-2023-00883
• Device Sequence Number: 15047439
• Product Code: LPH
• UDI-Device Identifier: 03596010232274
• UDI-Public: 03596010232274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71742854
• Device Catalogue Number: 71742854
• Device Lot Number: 01FM014307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71302800/COCR 12/14 FEM HEAD 28 +0
• Patient Sex: Unknown