MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI FEMORAL SZ3 LM/RL; KNEE FEMORAL COMPONENT

Catalog Number	102407300
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/28/2016
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.(b)(6).
Event or Problem Description
The patient was revised to address loosening in the femoral component.
Additional Manufacturer Narrative
The patient was revised to address loosening in the femoral component.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should 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: SIGMA HP UNI FEMORAL SZ3 LM/RL
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6800964
• Report Number: 1818910-2017-22961
• Device Sequence Number: 19122038
• Product Code: HRY
• UDI-Device Identifier: 10603295001737
• UDI-Public: 10603295001737
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K070849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 102407300
• Device Lot Number: 616949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 10/08/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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