MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 7-8 15MM; PRSTHSS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRAIND, CMNTD, POLY/MET/POLY

Model Number	71453261
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision of a poly insert was performed due its dovetail locking mechanism that seemed to be damaged.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it was reported that revision of a poly insert was performed due its dovetail locking mechanism that seemed to be damaged.To date, no medical information has been provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include poor insertion technique or device damaged during attempted use.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 warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN XLPE PS INSERT SZ 7-8 15MM
• Common Device Name: PRSTHSS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRAIND, CMNTD, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9478608
• Report Number: 1020279-2019-04416
• Device Sequence Number: 14185578
• Product Code: JWH
• UDI-Device Identifier: 00885556255773
• UDI-Public: 00885556255773
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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 Expiration Date: 10/15/2023
• Device Model Number: 71453261
• Device Catalogue Number: 71453261
• Device Lot Number: 13KM13058
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 03/11/2020
• 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