MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC KEEL TIB TRAY CEM SZ2; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-4180
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Upon review of the details of the complaint, it is apparent that there is clearly severe tibial insert polyethylene wear-through, as well as fracture damage of the tibial tray implant.The simple reported "instability" is less clear.While possibly caused by the unbalanced wear of the insert, it could also be patellar, or flexion or extension instability, involving other products--therefore, these cannot be ruled out, and are therefore reportable.Revision surgery: surgeon: (b)(6), hospital: (b)(6), date: (b)(6) 2019, reason for revision: instability.
Additional Manufacturer Narrative
Product complaint (b)(4).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.  h10 additional narrative:  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
It was reported that the affected side is the right knee.Removed sigma pli gvf ins 2 8mm, pfc*sigma/ov dome pat 3 peg,32, depuy cmw 1g 40g and pfc*sigma c/r npor fem rt sz 2 from d11 field.
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.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC KEEL TIB TRAY CEM SZ2
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9247172
• Report Number: 1818910-2019-112625
• Device Sequence Number: 10874562
• Product Code: JWH
• UDI-Device Identifier: 10603295216421
• UDI-Public: 10603295216421
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 86-4180
• Device Catalogue Number: 864180
• Device Lot Number: 2841464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 01/29/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/04/2019; 01/31/2020
• 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: DEPUY CMW 1G 40G; DEPUY CMW 2G 40G; PFC KEEL TIB TRAY CEM SZ2; PFC*SIGMA C/R NPOR FEM LT SZ 2; PFC*SIGMA C/R NPOR FEM RT SZ 2; PFC*SIGMA/OV DOME PAT 3 PEG,32; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIGMA PLI GVF INS 2 8MM; SIGMA PLI GVF INS 2 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR