MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421032
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with limited range of motion after right total knee arthroplasty for which manipulation under anesthesia was performed.
Additional Manufacturer Narrative
The associated journey ii bcs femoral oxinium, journey ii bcs articular insert, journey tibial baseplate and genesis ii oval resurfacing patella were not returned for evaluation.Therefore the product analysis could not be performed.However, device details were provided.Thus, the review of manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that based on a review of clinical documentation provided the cultures of the knee and lungs were found to be negative.It was also reported the patient received prophylactic antibiotics as well as anticoagulant therapy.The root cause of the pulmonary embolus could have been a risk of the procedure itself (tka).The limited range of motion was due to lack of rehab and physical therapy because of the reported pe and therefore both were not directly related to failure of the devices themselves.The patient impact beyond the reported pain and need for extended hospital stay is inconclusive.It was reported that the mua resolved the immobility issues and the pe was resolved with medication.No further clinical assessment is warranted at this time.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: GII OVAL RESURFACING PAT 32MM
• 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: 8584926
• Report Number: 1020279-2019-01787
• Device Sequence Number: 1809722
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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 Catalogue Number: 71421032
• Device Lot Number: 16HM09133
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 76