MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 LCS CMP/SIGMA REV FEM SLV 34MM; KNEE OTHER IMPLANT

Catalog Number	129453120
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer 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 femoral sleeve was unable to morse taper lock on to the adaptor of the srom hinge femur when assembling the definitive implants.
Additional Manufacturer Narrative
Evaluation and testing of the returned device was unable to confirm the reported event.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS CMP/SIGMA REV FEM SLV 34MM
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7075931
• Report Number: 1818910-2017-29655
• Device Sequence Number: 13730277
• Product Code: NJL
• UDI-Device Identifier: 10603295026228
• UDI-Public: 10603295026228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 129453120
• Device Lot Number: 347957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 12/01/2017
• 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