MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO CONF TB ISRT LT S5 10; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71507251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a knee surgery, the physician did a revision due to mobilization of the knee prosthesis and gonarthrosis.Condition of the patient is unknown.
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, without the requested clinical information or the device, a thorough medical investigation cannot be rendered, nor can the root cause of the reported failure cannot be determined.The impact to the patient beyond that which has been reported cannot be determined.Should any additional medical information be provided this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.Possible causes could include but not limited to traumatic injury, inflammation, patient condition, alignment or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: PRO CONF TB ISRT LT S5 10
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12053973
• Report Number: 1020279-2021-05406
• Device Sequence Number: 3324849
• Product Code: JWH
• UDI-Device Identifier: 03596010220448
• UDI-Public: 03596010220448
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K933958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 06/01/2023
• Device Model Number: 71507251
• Device Catalogue Number: 71507251
• Device Lot Number: D1307251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71501009, LOT: 12FTX0004A; 71522250, LOT: E1304911; 71524250, LOT: 10FM18043
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 72 YR