MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLKCVD PLUS INS 3 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	970452
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Fibrosis (3167); No Code Available (3191)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Medical records received 17 june 2019 and were reviewed 06 september 2019 for mdr reportability.On (b)(6) 2013, the patient underwent total right knee arthroplasty due to osteoarthritis.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications and patient was transferred to recovery in stable condition.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2013, the patient underwent a right knee manipulation due to stiffness.The surgeon indicated palpable lysis of adhesions were felt.The surgeon reported no intraoperative complications.On (b)(6) 2014, the patient underwent a right knee arthroscopy with resection of scar tissue.Due to pain.The surgeon reported the scar tissue was removed, and no interoperative complications.On (b)(6) 2016, the patient underwent a right knee revision due to loosening and arthrofibrosis.The surgeon noted the femoral component was not grossly loose but removed very easily, and the tibial component dis-impacted rather easily.The surgeon did not report which interfaces he found loosening.The patella was revised.The surgeon reported no intraoperative complications.Unknown components were implanted in this revision.Doi: (b)(6) 2013, dor: (b)(6) 2016 (rt knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA XLKCVD PLUS INS 3 12.5MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9125651
• Report Number: 1818910-2019-106472
• Device Sequence Number: 2614573
• Product Code: JWH
• UDI-Device Identifier: 10603295250562
• UDI-Public: 10603295250562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2019

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 Expiration Date: 01/31/2018
• Device Catalogue Number: 970452
• Device Lot Number: 334677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019; 10/21/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/04/2019; 10/25/2019
• 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: Required Intervention
• Patient Age: 60 YR