MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 1-2 9MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71453101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/02/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.Medial patellofemoral ligament reconstruction with semitendinosus allograft left knee and application of long leg immobilizer.No implants removed.
Event or Problem Description
It was reported that a medical intervention was performed.Several treatments were done such as analgesics, aspirations, scan tests, which ended up in a medial patellofemoral ligament reconstruction with semitendinosus allograft left knee and application of long leg immobilizer on (b)(6) 2015.No implants were removed at that point.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the available information, the root causes for the ¿lateral instability of the left patella, or the subsequent full revision surgery cannot be concluded.There has been no cause or reason revealed or speculated in any of the documents provided except the osteophytes and the possibility of osgood-schlatter¿s disease.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7924588
• Report Number: 1020279-2018-02046
• Device Sequence Number: 1624860
• Product Code: JWH
• UDI-Device Identifier: 00885556033432
• UDI-Public: 00885556033432
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2018

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: 09/30/2021
• Device Catalogue Number: 71453101
• Device Lot Number: 11KM00455
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 09/14/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/03/2018; 12/04/2018
• 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