MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71453121
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a manipulation under anesthesia due to arthrofibrosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation as conducted and the reported nickel allergy, slight varus orientation of 1° tibial component, recurrent arthrofibrotic/hyperplastic local tissue reactions, cachexia and the intraoperative complications are likely contributing factors to the reported events, however, the source of the intermittent systemic rash/reaction cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with the implant but they did resolve after the patellar revision, of note, the scarring and arthrofibrosis continued.The patient impact cannot be concluded because the cause is multi-factorial: the reported nickel allergy, that "she tends to form scar tissue rather quickly", osteoporosis, chronic pain and steroid use.The cause of the reported symptoms, (1st) partial revision, intraoperative complications x 2, manipulations x 2, and expected future (2nd) revision cannot be determined.Should additional clinically relevant documentation/information be provided, the clinical/medical investigation may be re-evaluated.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 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: 7684034
• Report Number: 1020279-2018-01282
• Device Sequence Number: 16507088
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Catalogue Number: 71453121
• Device Lot Number: 16HM19932
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/05/2018
• Patient Sequence Number: 1
• Patient Age: 73 YR