MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 11MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420818
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was diagnosed with a posterior dislocation of a previously well-functioning left total knee revision.This was thought secondary to the patient's weight of approximately 150 kg.The knee was reduced under anesthesia, posteriorly the surgeon proceed to removed the tibial component and replaced it with a 15 mm size 3/4 genesis ii constrained articular insert.
Event or Problem Description
It was reported that the patient was diagnosed with a posterior dislocation of a previously well-functioning left total knee revision.This was thought secondary to the patient's weight of approximately (b)(6).The knee was reduced under anestesia, posteriorly the surgeon proceed to removed the tibial component and replaced it with a 15 mm size 3/4 genesis ii constrained articular insert.Several treatments and medical interventions were done such as meds prescription, injections, ct scan tests, x-rays, which ended up in the closed reduction and poly exchange performed on (b)(6) 2017.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, 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 cause of the ¿aseptic loosening of the patella¿ of the first revision cannot be concluded.The root cause for the second revision was likely as stated the ¿posterior dislocation¿ and the observed laxity of the knee.It is unknown if the patient¿s body habitus contributed to this issue.No current information has been provided on this patient at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 3-4 11MM
• 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: 7928416
• Report Number: 1020279-2018-02095
• Device Sequence Number: 13969104
• Product Code: JWH
• UDI-Device Identifier: 03596010209580
• UDI-Public: 03596010209580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

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: 05/27/2019
• Device Catalogue Number: 71420818
• Device Lot Number: 09EM20074
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 09/14/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/04/2018; 12/11/2018
• 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: 71421142/LGN HM ST 3-4 5MM LTMD-RTLA/08HM08617; 71421146/LGN HM ST 3-4 5MM LTLA-RTMED/09AM12811; 71421165/LGN OX CONSTRAINED FEM 5 LT/09LM00653; 71421741/LEGION SCW LWDG S5 5DX5P/09EM10976; 71421742/LEGION SCW LWDG S5 5DX10P/05JM09977; 71424004/LGN REV TIBIA BASE SZ 4 LT/09DM07569; 71424049/LGN PRESSFIT STEM 16MMX160MM/08MAB0014D; 71424049/LGN PRESSFIT STEM 16MMX160MM/09EAB0002A; 71424225/LGN OFFSET COUPLER 4MM/09FM01338; 71424227/LGN OFFSET COUPLER 6MM/09FM20040
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 150