MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER 4MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71424225
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed to exchange a broken offset coupler.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that the x-ray provided shows loosening around the stem and under the baseplate and likely led to the broken component.However, without the request clinical information, operative report, or the broken offset coupler, the root cause of the loosening cannot be determined.The impact to the patient beyond the revision cannot be determined.Should any additional clinical information be provided this complaint will be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 of the reported event could include but are not limited to device loosening or abnormal loading.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN OFFSET COUPLER 4MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9255862
• Report Number: 1020279-2019-03825
• Device Sequence Number: 11677589
• Product Code: JWH
• UDI-Device Identifier: 03596010547132
• UDI-Public: 03596010547132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Model Number: 71424225
• Device Catalogue Number: 71424225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention